European Authorized Representative Center

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Personal Protective Equipment Directive 89/686/EEC Services



Eaar Member
EAAR MEMBER

ISO 9001:2001
ISO 9001:2001

Services for Non-European Medical devices Manufacturers:

The concept "Category"
PPE (Personal Protective Equipment) protects its intended user against one or more hazards. Exposure to hazards may lead to injury. The seriousness of these injuries has been categorized as follows: category I (less serious injuries), category III (very serious injuries leading to irreversible harm to health and/or death) and category II summarizing the remaining degrees of seriousness of injuries.

Services for Category I Personal Protective Equipment

Services for Category II Personal Protective Equipment

Services for Category III Personal Protective Equipment

 

Services for Category I Personal Protective Equipment

  • Obelis European Authorized Representative provides assistance in complying with EC Declaration of Conformity     Category I (PPE 89/686/EEC art.8,1).
  • Obelis European Authorized Representative becomes your independent authorized representative towards the     European competent authorities, European notified bodies, distributors and European users (PPE 89/686/EEC art.8,1).
  • Obelis European Authorized Representative address on the product related printing materials i.e. product     instructions, packaging, Risk label, Use Restriction sheet (PPE 89/686/EEC,Annex II, 1.4).
  • Obelis European Authorized Representative holds the product Technical File available for the EU Competent Authorities     Review (PPE 89/686/EEC, Article 10,5).
  • Obelis European Authorized Representative Identifies the official language of the destination country, and     recommendation of translator service.
  • Obelis European Authorized Representative offers Identification of appropriate product category free of charge.
  • Services for Category II Personal Protective Equipment

  • Obelis European Authorized Representative provides assistance in complying with EC Declaration of Conformity     Category II. (PPE 89/686/EEC art.8,1)
  • Obelis European Authorized Representative upon request may coordinate EC examination by European Notified Body     (89/686/EEC art.8, 2
  • Obelis EuropeanAuthorized Representative becomes your independent authorized representative towards the     European competent authorities, European notified bodies, distributors and European users. (PPE 89/686/EEC art.8,1)
  • Obelis EuropeanAuthorized Representative address on the product related printing materials i.e. product instructions,     packaging, Risk label, Use Restriction sheet (PPE 89/686/EEC,Annex II, 1.4).
  • Obelis European Authorized Representative holds the product Technical File available for the EU Competent Authorities     Review (PPE 89/686/EEC, Article 10,5).
  • Obelis European Authorized Representative Identifies the official language of the destination country, and     recommendation of translator service.
  • Obelis European Authorized Representative offers Identification of appropriate product category free of charge.
  • Services for Category III Personal Protective Equipment


  • Obelis European Authorized Representative upon request may coordinate of EC Examination Service and Quality     Control (89/686/EEC art.8, 2)
  • Full Category III Declaration Services. (PPE 89/686/EEC art.8,1)
  • Obelis European Authorized Reprtesentative becomes your independent authorized representative towards the     competent authorities, notified body, distributors and European users. (PPE 89/686/EEC art.8,1)
  • Obelis European Authorized Reprtesentative address on the product related printing materials i.e. product instructions,     packaging, Risk label, Use Restriction sheet (PPE 89/686/EEC,Annex II, 1.4).
  • Obelis European Authorized Reprtesentative holds the product Technical File available for the EU Competent Authorities     Review (PPE 89/686/EEC,Article 10,5).
  • Obelis European Authorized Representative Identifies the official language of the destination country, and     recommendation of translator service.
  • Obelis European Authorized Representative offers Identification of appropriate product category free of charge.


  • Contact us for our services, your questions, and our assistance.


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