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Autokit 3-HB R2 Set
EUDAMEDClass B (EU MDR)
Ref 994-73601Model 998-73501, 994-73601
Identity
- Trade Name
- Autokit 3-HB R2 Set EUDAMED
- Device Name
- Autokit 3-HB R1 Set, Autokit 3-HB R2 Set EUDAMED
- Model / Reference
- 998-73501, 994-73601 EUDAMED994-73601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987481164796 EUDAMED
- Basic UDI-DI
- 49874814987481164789VS EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Autokit 3-HB R2 Set by Fujifilm Wako Pure Chemical Corporation — Class B — 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 | 49874814987481164789VS | Class B | Active |
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Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (1)
- EUDAMED 666070b5-ce59-4bb9-ae68-699865d9df13 61 fields · synced Oct 6, 2026