Identity
- Trade Name
- FUJI DRI-CHEM CLEAN TIPS EUDAMED
- Device Name
- FUJI DRI-CHEM CLEAN TIPS EUDAMED
- Model / Reference
- 04902520282514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04902520282514 EUDAMED
- Basic UDI-DI
- 4547410301000000000003873 EUDAMED
- Unit of Use DI
- 84902520282510 EUDAMED
- EMDN Code
- W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Fuji Dri-Chem Clean Tips by FUJIFILM Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4547410301000000000003873 | Class A | 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 708b8740-e7fe-4888-9189-8e5d84734197 61 fields · synced Jun 20, 2026