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Notification

Found : 16
  Body (History):

INSTYTUT WLOKIENNICTWA
ul. Brzezinska 5/15
92-103 Lodz
Country : Poland

Phone : +48 42 61 63 101
Fax : +48 42 67 92 638

Email : info@iw.lodz.pl
Website : www.iw.lodz.pl

Notified Body number : 1435

Version(s): 1 2 3 4 5 6

Last update : 19/07/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 19/07/2010                 Version(s): 1 2 3

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 verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
Only For medical devices from rubber or plastic materials or with substantial part from rubber or plastic materials. Soda lime carbon dioxide absorbent with the rate a medical devices equipment. 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
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
Only Non-invasive devices intended for channeling or storing blond or body liquids, made of plastic. 
   - *MD 0104 - Non-active medical devices with measuring function
EC verification
Production quality assurance
Product quality assurance
Annex IV
Annex V
Annex VI
Only Feeders to medicines and bowls, glasses and other tensils dental. 
   - *MD 0106 - Non-active instruments
Production quality assurance Annex V Only Single use non-invasive medical devices. 
   - *MD 0107 - Contraceptive medical 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
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
Only Products intended to be used for disinfecting of medical devices equipment. 
*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
Only Invasive, non active implants made of textiles. 
   - *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
Only Invasive, non active implants made of textiles. 
   - *MD 0204 - Non-active soft tissue 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
Only Invasive, non active implants made of textiles. 
*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
 
   - *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
Only Surgical threads, natural and synthetic. 
*MD 1100 - General active medical devices
 
   - *MD 1104 - Active surgical devices
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
Only Active therapeutic devices intended to administer or exchange energy. 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC  
*MDS 7005 - Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Only 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  
*MDS 7008 - Medical devices utilising nanomaterials  
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