FUJI Medical X-ray Film
by FUJIFILM Corporation Japan EUDAMED
Ref 4741019288
EMDN Z130101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4547410101000000000000132 | Date25 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 4203162CE01 Amended
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 15 Jul 2024
- Expires
- 27 Jun 2029
- Reason
- Mnf ar change
Specification
- Model / Reference
- 4741019288
- Primary DI / UDI-DI
- 04547410192889
- Basic UDI-DI
- 4547410101000000000000132
- Unit of Use DI
- 84547410192885
- EMDN Code
- Z130101 General purpose x-ray films
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000010401
- Authorised representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 7f768df1-21fe-4dcb-a585-423c0e262719