Identity
- Trade Name
- FUJI Medical X-ray Film EUDAMEDFDA UDI
- Generic Name
- Medical x-ray film, screen FDA UDI
- Device Name
- FUJI Medical X-ray Film EUDAMEDFDA UDI
- Model / Reference
- 4741012974 EUDAMEDSUPER HR-U 18X43 500 E ** FDA UDI
- Description
- FUJI MEDICAL X-RAY FILM FDA UDI
Identifiers
- Catalog Number
- 4741012974 FDA UDI
- Primary DI / UDI-DI
- 04547410129748 EUDAMEDFDA UDI
- Basic UDI-DI
- 4547410101000000000000132 EUDAMED
- Unit of Use DI
- 84547410129744 EUDAMED
- FDA Product Code
- IWZ FDA UDI
- EMDN Code
- Z130101 GENERAL PURPOSE X-RAY FILMS EUDAMED
- GMDN Term
- Medical x-ray film, screen FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1840 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FUJI Medical X-ray Film by FUJIFILM Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4547410101000000000000132 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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 (2)
- EUDAMED 23996e41-961d-4fdb-86e2-f037bcf61559 61 fields · synced Jun 15, 2026
- FDA UDI 0f3fd37c-0945-40db-a99a-e0d9139ebca9 37 fields · synced May 30, 2026