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Bodies
Found : 20
Search criteria :
Legislation :
Regulation (EU) 2017/745 on medical devices
Procedure /
Article or annex :
ALL
Conformity assessment based on a quality management system / Annex IX(I)
Conformity assessment based on assessment of technical documentation / Annex IX(II)
Conformity assessment based on product conformity verification / Annex XI(B)
Conformity assessment based on product quality assurance / Annex XI(A)
Conformity assessment based on type-examination / Annex X
Products :
ALL
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
A. Active devices
1. Active implantable devices
MDA 0101 Active implantable devices for stimulation/inhibition/monitoring
MDA 0102 Active implantable devices delivering drugs or other substances
MDA 0103 Active implantable devices supporting or replacing organ functions
MDA 0104 Active implantable devices utilising radiation and other active implantable devices
2. Active non-implantable devices for imaging, monitoring and/or diagnosis
MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
3. Active non-implantable therapeutic devices and general active non-implantable devices
MDA 0301 Active non-implantable devices utilising ionizing radiation
MDA 0302 Active non-implantable devices utilising non-ionizing radiation
MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)
MDA 0305 Active non-implantable devices for stimulation or inhibition
MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and h...
MDA 0307 Active non-implantable respiratory devices
MDA 0308 Active non-implantable devices for wound and skin care
MDA 0309 Active non-implantable ophthalmologic devices
MDA 0310 Active non-implantable devices for ear, nose and throat
MDA 0311 Active non-implantable dental devices
MDA 0312 Other active non-implantable surgical devices
MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including i...
MDA 0315 Software
MDA 0316 Medical gas supply systems and parts thereof
MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
MDA 0318 Other active non-implantable devices
B. Non-active devices
1. Non-active implants and long term surgically invasive devices
MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
MDN 1102 Non-active osteo- and orthopaedic implants
MDN 1103 Non-active dental implants and dental materials
MDN 1104 Non-active soft tissue and other implants
2. Non-active non-implantable devices
MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devi...
MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related...
MDN 1204 Non-active non-implantable devices for wound and skin care
MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
MDN 1206 Non-active non-implantable ophthalmologic devices
MDN 1207 Non-active non-implantable diagnostic devices
MDN 1208 Non-active non-implantable instruments
MDN 1209 Non-active non-implantable dental materials
MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually tran...
MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs includin...
MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body or...
MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
1. Devices with specific characteristics
MDS 1001 Devices incorporating medicinal substances
MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives
MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2...
MDS 1005 Devices in sterile condition
MDS 1006 Reusable surgical instruments
MDS 1007 Devices incorporating or consisting of nanomaterial
MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locall...
MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for con...
MDS 1010 Devices with a measuring function
MDS 1011 Devices in systems or procedure packs
MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
MDS 1013 Class III custom-made implantable devices
MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device
2. Devices for which specific technologies or processes are used
MDT 2001 Devices manufactured using metal processing
MDT 2002 Devices manufactured using plastic processing
MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
MDT 2005 Devices manufactured using biotechnology
MDT 2006 Devices manufactured using chemical processing
MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
MDT 2008 Devices manufactured in clean rooms and associated controlled environments
MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
MDT 2010 Devices manufactured using electronic components including communication devices
MDT 2011 Devices which require packaging, including labelling
MDT 2012 Devices which require installation, refurbishment
MDT 2013 Devices which have undergone reprocessing
Horizontal technical competence :
ALL
MDS 1001 Devices incorporating medicinal substances
MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives
MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2...
MDS 1005 Devices in sterile condition
MDS 1006 Reusable surgical instruments
MDS 1007 Devices incorporating or consisting of nanomaterial
MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locall...
MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for con...
MDS 1010 Devices with a measuring function
MDS 1011 Devices in systems or procedure packs
MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
MDS 1013 Class III custom-made implantable devices
MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device
MDT 2001 Devices manufactured using metal processing
MDT 2002 Devices manufactured using plastic processing
MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)
MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)
MDT 2005 Devices manufactured using biotechnology
MDT 2006 Devices manufactured using chemical processing
MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals
MDT 2008 Devices manufactured in clean rooms and associated controlled environments
MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
MDT 2010 Devices manufactured using electronic components including communication devices
MDT 2011 Devices which require packaging, including labelling
MDT 2012 Devices which require installation, refurbishment
MDT 2013 Devices which have undergone reprocessing
Withdrawn/Expired/Suspended Notifications/NBs are not displayed in this list, you can find them in the Body module under the hyperlink
"Withdrawn/Expired/Suspended Notifications/NBs"
Body type
Name
Country
NB 2265
3EC International a.s.
Slovakia
NB 2797
BSI Group The Netherlands B.V.
Netherlands
NB 2409
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Hungary
NB 1912
DARE!! Services B.V.
Netherlands
NB 0344
DEKRA Certification B.V.
Netherlands
NB 0124
DEKRA Certification GmbH
Germany
NB 2460
DNV Product Assurance AS
Norway
NB 0297
DQS Medizinprodukte GmbH
Germany
NB 0537
Eurofins Expert Services Oy
Finland
NB 0459
GMED
France
NB 0051
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Italy
NB 0373
ISTITUTO SUPERIORE DI SANITA'
Italy
NB 2862
Intertek Medical Notified Body AB
Sweden
NB 0483
MDC MEDICAL DEVICE CERTIFICATION GMBH
Germany
NB 0482
MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
Germany
NB 0050
National Standards Authority of Ireland (NSAI)
Ireland
NB 0598 (ex-0403)
SGS FIMKO OY
Finland
NB 0197
TÜV Rheinland LGA Products GmbH
Germany
NB 0123
TÜV SÜD Product Service GmbH Zertifizierstellen
Germany
NB 2696
UDEM Adriatic d.o.o.
Croatia