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Notification

Found : 18
 
  Body (History):

Kiwa Dare B.V.
Vijzelmolenlaan 7
NL-3447 GX Woerden
Country : Netherlands

Phone : +31 348 200 900
Fax : -

Email : medcert@dare.nl
Website : www.dare.nl

Notified Body number : 1912

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Last approval date : 04/01/2022
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 21/09/2018                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to devices for administration and removal of substances Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices inhalation anaesthesia, lung ventilators and heart-lung machines are excluded 
   - *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1106 - Active dental devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1109 - Active devices for patient positioning and transport
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system) Annex II Limited to non sterile class Im, IIa and IIb devices 
*MD 1200 - Devices for imaging
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex II
Annex V
Limited to non sterile class Im, IIa and IIb devices 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery Limited to non sterile class Im, IIa and IIb devices
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software Limited to non sterile class Im, IIa and IIb devices