Identity
- Trade Name
- FUJI DRI-CHEM AUTO TIPS EUDAMED
- Device Name
- FUJI DRI-CHEM AUTO TIPS EUDAMED
- Model / Reference
- 04547410033144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547410033144 EUDAMED
- Basic UDI-DI
- 454741030100000000000376Z EUDAMED
- Unit of Use DI
- 84547410033140 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 Auto 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 | 454741030100000000000376Z | 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 92bb682e-11cd-4f06-bc70-6b38ab6c9f03 61 fields · synced Jun 19, 2026