0483
mdc medical device certification GmbH
Designations
Conformity assessment annexesAnnex VI, Annex III, Annex II, Annex V
Designated since2006-04-09
Full scope text from the register
Annexes
- Annex VI, Annex III, Annex II, Annex V
Procedures
- EC type-examination, Production quality assurance, Product quality assurance, Full quality assurance system
Products
- with non-ionizing radiation
- imaging equipment
- with ionizing radiation
- dental equipment
- ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapy
- medical supply units
- Active medical devices
- infusion devices
- patient storage and transport equipment
- radiotherapy devices
- with ionizing radiation and with non-ionizing radiation
- prostheses and rehabilitation devices
- devices to monitor and determine vital signs
- Non-active medical devices
- ophtalmological devices
- surgical devices and aids, except for lithotripsy devices
- stimulators, except external pacemakers and defibrillators
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=0483
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0483
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.