Identity
- Trade Name
- IRM-Set EUDAMED
- Device Name
- IRM-Set EUDAMED
- Model / Reference
- 390504 EUDAMED390504-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858344898 EUDAMED04054858345307 EUDAMED
- Basic UDI-DI
- 40548583905042Z EUDAMED4054858390504-1KD EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Set zur Verabreichung von Kontrastmittel in der Radiologie und Nuklearmedizin EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
IRM-Set by Fuhrmann GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40548583905042Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (2)
- EUDAMED 9bbc9fbd-b636-474b-b88b-e2227022621d 61 fields · synced Jul 12, 2026
- EUDAMED ed854819-d63e-4888-aa2a-baaddc6c190b 61 fields · synced May 19, 2026