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0633

Berlin Cert GmbH

🇩🇪 Germany · BERLIN Active

www.berlincert.de

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex VI, Annex IV, Annex V, Annex II
Designated since2017-03-14
Full scope text from the register
Annexes
  • Annex VI, Annex IV, Annex V, Annex II
Procedures
  • EC declaration of conformity (full quality assurance system), EC declaration of conformity (product quality assurance), EC verification, EC declaration of conformity (production quality assurance)
Products
  • *MD 1402 - Devices utilising non-ionizing radiation
  • *MD 1103 - Devices for stimulation or inhibition
  • *MD 1400 - Devices for radiation therapy and thermo therapy
  • *MD 1104 - Active surgical devices
  • *MD 1301 - Monitoring devices of non-vital physiological parameters
  • *MD 1111 - Software
  • *MD 1302 - Monitoring devices of vital physiological parameters
  • *MD 1106 - Active dental devices
  • *MD 1100 - General active medical devices
  • *MD 1202 - Imaging devices utilising non-ionizing radiation
  • *MD 1200 - Devices for imaging
  • *MD 0100 - General non-active, non-implantable medical devices
  • *MD 0103 - Non-active orthopaedic and rehabilitation devices
  • *MD 0106 - Non-active instruments
  • *MD 1300 - Monitoring devices
  • *MD 1112 - Medical gas supply systems and parts thereof
  • *MD 1403 - Devices for hyperthermia / hypothermia
  • *MD 1109 - Active devices for patient positioning and transport
  • *MD 1105 - Active ophthalmologic devices
  • *MD 1107 - Active devices for disinfection and sterilisation
  • *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
  • *MD 1108 - Active rehabilitation devices and active prostheses
  • *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex VI, Annex IV, Annex V, Annex II
Designated since2017-03-14
Full scope text from the register
Annexes
  • Annex VI, Annex IV, Annex V, Annex II
Procedures
  • EC declaration of conformity (full quality assurance system), EC declaration of conformity (product quality assurance), EC verification, EC declaration of conformity (production quality assurance)
Products
  • *MD 1402 - Devices utilising non-ionizing radiation
  • *MD 1103 - Devices for stimulation or inhibition
  • *MD 1400 - Devices for radiation therapy and thermo therapy
  • *MD 1104 - Active surgical devices
  • *MD 1301 - Monitoring devices of non-vital physiological parameters
  • *MD 1111 - Software
  • *MD 1302 - Monitoring devices of vital physiological parameters
  • *MD 1106 - Active dental devices
  • *MD 1100 - General active medical devices
  • *MD 1202 - Imaging devices utilising non-ionizing radiation
  • *MD 1200 - Devices for imaging
  • *MD 0100 - General non-active, non-implantable medical devices
  • *MD 0103 - Non-active orthopaedic and rehabilitation devices
  • *MD 0106 - Non-active instruments
  • *MD 1300 - Monitoring devices
  • *MD 1112 - Medical gas supply systems and parts thereof
  • *MD 1403 - Devices for hyperthermia / hypothermia
  • *MD 1109 - Active devices for patient positioning and transport
  • *MD 1105 - Active ophthalmologic devices
  • *MD 1107 - Active devices for disinfection and sterilisation
  • *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
  • *MD 1108 - Active rehabilitation devices and active prostheses
  • *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0633

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.