Synapse 3D
by FUJIFILM Corporation Japan EUDAMED
Ref SYNAPSE 3D SOFT V7.2 E
EMDN Z11069092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number454741040100000000000328C | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- SYNAPSE 3D SOFT V7.2 E
- Primary DI / UDI-DI
- 04547410575385
- Basic UDI-DI
- 454741040100000000000328C
- EMDN Code
- Z11069092 Various digital bioimaging management instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000010401
- Authorised representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Other devices from Fujifilm Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 04547410575385|454741040100000000000328C