Navigation path


Notification

Found : 32
  Body :

CERTIQUALITY S.R.L. - ISTITUTO DI CERTIFICAZIONE DELLA QUALITA'
Via G. Giardino, 4
20123 - MILANO
Country : Italy

Phone : +39 02 8069171
Fax : +39 02 86465295

Email : certiquality@certiquality.it
Website : www.certiquality.it

Notified Body number : 0546

Version(s): 1 2 3 4

Last update : 05/01/2009
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 21/08/2012                 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
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0105 - Non-active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0106 - Non-active instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0107 - Contraceptive medical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
*MD 0200 - Non-active implants
 
   - *MD 0202 - Non-active orthopaedic implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0203 - Non-active functional implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0204 - Non-active soft tissue implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0302 - Suture material and clamps
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0303 - Other medical devices for wound care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0402 - Dental materials
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
   - *MD 0403 - Dental implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source. Exclusion medical devices class III 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source. Exclusion hyperbaric chambers. Exclusion medical devices class III 
   - *MD 1104 - Active surgical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source.Exclusion medical devices class III 
   - *MD 1106 - Active dental devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source.Exclusion medical devices class III 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source.Exclusion medical devices class III 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source.Exclusion medical devices class III 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Only those charged with indipendent power source.Exclusion medical devices class III 
 
Horizontal technical competence Limitations
*MDS 7006 - Medical devices in sterile condition Exclusion medical devices class III
Set page to normal font size Increase font size by 200 percentprint this page