Identity
- Trade Name
- FUJI Medical X-ray Film EUDAMED
- Device Name
- FUJI Medical X-ray Film EUDAMED
- Model / Reference
- 4741033593 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547410335934 EUDAMED
- Basic UDI-DI
- 4547410101000000000000132 EUDAMED
- Unit of Use DI
- 84547410335930 EUDAMED
- EMDN Code
- Z130101 GENERAL PURPOSE X-RAY FILMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FUJI Medical X-ray Film by FUJIFILM Corporation — 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 | 4547410101000000000000132 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
- EUDAMED SRN
- JP-MF-000010401
- Authorised Representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Sources (1)
- EUDAMED b59b0e2f-38dd-4786-afa6-1628d6154c98 61 fields · synced Jun 15, 2026