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Notification

Found : 10
  Body :

TEXTILNÍ ZKUŠEBNÍ ÚSTAV s.p.
Václavská 6
658 41 BRNO
Country : Czech Republic

Phone : +420::543426711
Fax : +420::543243590

Email : malcik@tzu.cz
Website : www.tzu.cz

Notified Body number : 1021

Version(s): 1 2 3

Last update : 23/10/2008
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 13/04/2010                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
*MD 0200 - Non-active implants
 
   - *MD 0201 - Non-active cardiovascular implants
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
   - *MD 0202 - Non-active orthopaedic implants
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
   - *MD 0302 - Suture material and clamps
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI  
   - *MD 0303 - Other medical devices for wound care
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
For medical devices from textile materials or with substantial part from textile materials - Annex II, III, IV, V, VI ; For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials - Annex II, V, VI  
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013) Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7003 - Medical devices incorporating derivates of human blood, according to Directive 2000/70/EC, amended by Directive 2001/104/EC Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7005 - Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7006 - Medical devices in sterile condition Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7008 - Medical devices utilising nanomaterials Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed Medical devices from textile materials or with substantial part from textile materials; Medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials.
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