Medical device manufacturers in Romania
Look up medical device manufacturers, authorised representatives, importers, and system producers registered worldwide.
A manufacturer places a medical device on the EU market under its own name and is responsible for its conformity.
186 Medical device manufacturers in Romania registered in EUDAMED
Role and obligations in EUDAMED
A manufacturer is the legal entity that develops a medical device and places it on the EU market under its own name, bearing primary responsibility for the device’s conformity (MDR 2017/745, Article 10).
Medical device companies in Romania
Top locations in Romania: Bucuresti, Bucharest, Cluj-Napoca, Iasi, Brasov.
Competent authority in Romania
Medical devices placed on the market in Romania are overseen by its national competent authority for market surveillance: ANMDMR.
Frequently asked questions
What is a medical device manufacturer?
A manufacturer is the legal entity responsible for placing a medical device on the EU market under its own name and ensuring it meets the requirements of the MDR (2017/745) or the IVDR — règlement (UE) 2017/746.
Do manufacturers have to register in EUDAMED?
Yes. Manufacturers obtain a Single Registration Number (SRN) and register their actor and device data in EUDAMED.
Where are these manufacturers based?
EUDAMED lists manufacturers registered worldwide; you can filter this list by country.