Identity
- Trade Name
- FCR PRIMA T EUDAMED
- Device Name
- CR-IR 392 EUDAMED
- Model / Reference
- 04547410542462 EUDAMED04547410542479 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547410542462 EUDAMED04547410542479 EUDAMED
- Basic UDI-DI
- 454741010100000000000343H EUDAMED
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS 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
Fcr Prima T 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 | 454741010100000000000343H | Class IIa | Active |
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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 213d9b73-127b-49b5-8def-d9073a8fdfd9 61 fields · synced Jul 9, 2026
- EUDAMED 23359d8c-fb2c-48c7-8cec-4257c7d75cf8 61 fields · synced May 17, 2026