European Commission - Growth

For a better experience, please enable Javascript!


Notification

Found : 40
 
  Body :

Eurofins Product Testing Italy S.r.l.
Via Courgnè, 21
10156 - TORINO (TO)
Country : Italy

Phone : +39 011 2222225
Fax : +39 011 2222226

Email : tech@eurofins.com
Website : http://tech.eurofins.it

Notified Body number : 0477

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices         (History)
Last approval date : 20/04/2018                 Version(s): 1 2 3 4

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
Excluding class III medical devices 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *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
Excluding class III medical devices 
   - *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
Excluding class III medical devices 
   - *MD 0105 - Non-active ophthalmologic devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0106 - Non-active instruments
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0107 - Contraceptive medical devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
*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
Excluding class III medical devices 
   - *MD 0203 - Non-active functional implants
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0303 - Other medical devices for wound care
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0402 - Dental materials
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
   - *MD 0403 - Dental implants
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices 
*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
Excluding class III medical devices 
   - *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
Excluding class III medical devices 
   - *MD 1103 - Devices for stimulation or inhibition
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 class IIa medical devices 
   - *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
Excluding class III medical devices 
   - *MD 1105 - 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
Excluding class III medical devices 
   - *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
Excluding class III medical devices 
   - *MD 1107 - Active devices for disinfection and sterilisation
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
Excluding class III medical devices 
   - *MD 1108 - Active rehabilitation devices and active prostheses
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
Excluding class III medical devices 
   - *MD 1109 - Active devices for patient positioning and transport
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
Excluding class III medical devices 
   - *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
Excluding class III medical devices 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
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
Excluding class III medical devices 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
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
Excluding class III medical devices and devices for magnetic resonance 
*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
Excluding class III medical devices 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
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
Excluding class III medical devices 
   - *MD 1402 - Devices utilising non-ionizing radiation
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
Excluding class III medical devices 
   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
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
Excluding class III medical devices 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery Excluding class III medical devices
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices