Identity
- Trade Name
- 898Y101490 EUDAMED
- Device Name
- Lateral Option EUDAMED
- Model / Reference
- 04547410242331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547410242331 EUDAMED
- Basic UDI-DI
- 454741010100000000000913V EUDAMED
- EMDN Code
- Z1103028001 STEREOTACTIC MODULES FOR MAMMOGRAPHY EUDAMED
Classification
- Device Class
- Class I 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
898y101490 by FUJIFILM Corporation — Class I — 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 | 454741010100000000000913V | Class I | 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 90940b0a-5815-4802-abd5-873302202306 61 fields · synced Jun 19, 2026