EU-declaration of Conformity - ADVYS · 2018. 6. 18. · EU-declaration of Conformity Fabricant :...
Transcript of EU-declaration of Conformity - ADVYS · 2018. 6. 18. · EU-declaration of Conformity Fabricant :...
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6021 Description : VELA Tango 100 Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
January 9th, 2015
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6025 Description : VELA Tango 100A with CX coxit-seat Class : Therapy Chair Class 180909 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
12. November 2012
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6017 Description : VELA Tango 100B Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6151 Description : VELA Tango 100E Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. 9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Manufacturer : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that
Product : Ref.No. : 6139 Description : VELA Tango 100EF Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. January 9th, 2015
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity
Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6152 Description : VELA Tango 100ES Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 80 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. 9. December 2013
Michael Vestergaard
Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6019 Description : VELA Tango 100F Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6018 Description : VELA Tango 100FB Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6022 Description : VELA Tango 200 Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Manufacturer : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6149 Description : VELA Tango 200EF with CY coxit seat Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. 9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6029 Description : VELA Tango 200F Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 6028 Description : VELA Tango 200FB Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with
EC COUNCIL DIRECTIVE MDD 93/42/EEC of 14. June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 5024 Description : VELA Tango 300 Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 200 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices.
9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity Fabricant : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that Product : Ref.No. : 5105 Description : VELA Tango 300E Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 200 Kg. Are in conformity with
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, with all later changes. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII.
And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods.
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. 9. December 2013
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration of Conformity
Manufactor: Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 8-12 Gøteborgvej 8-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166 Hereby declare that Product : Item no. : 6045 Description : VELA Tango 500 Class : Office Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with COUNCIL DIREKTIVE 93/42/ECC of 14 June 1993 concerning medical devices.
Product falling under Class I and labelled with the CE in accordance with the procedure, as described in Annex VII.
And have been tested under
DS/EN 1335-1:2001 Dimensions – Determinations of dimensions DS/EN 1335-2:2009 Safety requirements. DS/EN 1335-3:2009 Test methods.
EN1021-1:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent.
And satisfies all essential requirements with reference to EN12182:2012 Techcal aids for the disabled – General requirements and test methods.
That a risk analysis has been made and is available
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices.
21. March 2018
Anders Hauerberg Hansen
Design Manager
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EU-declaration of Conformity Manufacturer : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that
Product : Ref.No. : 6155 Description : VELA Tango 500E Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII. And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods. EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent.
And satisfy all vital demands in reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available
EN ISO 14971 Medical devices – Application of risk management to medical devices. 02. July 2015
Michael Vestergaard Manager, Product Development and Strategic Procurement
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EU-declaration og Conformity
Manufactor : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 8-12 Gøteborgvej 8-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166 Hereby declare that Product : Item no. : 6046 Description : VELA Tango 510 Class : Office Chair Class 180903 Capacity : Max. user weight recommende 160 Kg. Are in conformity with COUNCIL DIREKTIVE 93/42/ECC of 14 June 1993 concerning medical devices. Product falling under Class I and labelled with the CE in accordance with the procedure, as described in Annex VII. And have been tested under
DS/EN 1335-1:2001 Dimensions – Determinations of dimensions DS/EN 1335-2:2009 Safety requirements. DS/EN 1335-3:2009 Test methods.
EN1021-1:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent.
And satisfies all essential requirements with reference to EN12182:2012 Technical aids for the disabled – General requirements and test methods
That a risk analysis has been made and is available EN ISO 14971:2012 Medical devices – Application of risk management to medical devices.
21. March 2018
Anders Hauerberg Hansen
Design Manager
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EU-declaration of Conformity Manufactor : Vermund Larsen A/S Distributor: Vermund Larsen A/S Gøteborgvej 10-12 Gøteborgvej 10-12 9200 Aalborg 9200 Aalborg Danmark Danmark Tlf.: +45 96347600 Tlf.: +45 96347600 Fax.: +45 98187166 Fax.: +45 98187166
Hereby declare that
Product : Item no. : 6156 Description : VELA Tango 510E Class : Therapy Chair Class 180903 Capacity : Max. user weight recommended 160 Kg. Are in conformity with COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. Product falling under Class I and labeled with the CE in accordance with the procedure as described in Annex VII. And have been tested under EN 1335-1: Dimensions – Determinations of dimensions EN 1335-2: Safety requirements. EN 1335-3: Test methods. EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN1021-1 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette. EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent.
And satisfies all essential requirements with reference to EN 12182 Technical aids for disabled persons – General requirements and test methods
That a risk analysis has been made and is available EN ISO 14971 Medical devices – Application of risk management to medical devices.
21. March 2018
Anders Hauerberg Hansen Design Manager