Identity
- Trade Name
- FCR PRIMA T2 EUDAMED
- Device Name
- CR-IR 392 EUDAMED
- Model / Reference
- 04547410542493 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547410542493 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 T2 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 (1)
- EUDAMED 57396bbf-53b2-41b3-a7c0-49aa700c8edd 61 fields · synced Oct 6, 2026