Identity
- Trade Name
- Fuji Medical Dry Imaging Film EUDAMEDFUJI MEDICAL DRY FILM FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- Fuji Medical Dry Imaging Film EUDAMEDMEDICAL DRY IMAGING FILM 100NIF 35x43 FDA UDI
- Model / Reference
- 4741022257 EUDAMEDDI-HL 35X43 100 == FDA UDI
- Description
- MEDICAL DRY IMAGING FILM 100NIF 35x43 FDA UDI
Identifiers
- Catalog Number
- 4741022257 FDA UDI
- Primary DI / UDI-DI
- 04547410222579 EUDAMEDFDA UDI
- Basic UDI-DI
- 454741010100000000000002Y EUDAMED
- Unit of Use DI
- 84547410222575 EUDAMED
- 510(k) Number
- K033377 FDA UDI
- FDA Product Code
- LMC FDA UDI
- EMDN Code
- Z130107 FILMS FOR REPRODUCTION FROM LASER TECHNOLOGIES EUDAMED
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2040 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
No
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 Dry Imaging Film by FUJIFILM Corporation — Class I — 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 | 454741010100000000000002Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
- EUDAMED SRN
- JP-MF-000010401
- Authorised Representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Sources (2)
- EUDAMED f08a0447-fb0a-4631-9b1b-bffe7ac3e750 61 fields · synced Jun 18, 2026
- FDA UDI 4dbabced-a492-436f-b773-1ce63c50dae9 38 fields · synced May 30, 2026