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Autokit Total Ketone Bodies R2 Set
EUDAMEDClass B (EU MDR)
Ref 992-73401Model 996-73301, 992-73401
Identity
- Trade Name
- Autokit Total Ketone Bodies R2 Set EUDAMED
- Device Name
- Autokit Total Ketone Bodies R1 Set, Autokit Total Ketone Bodies R2 Set EUDAMED
- Model / Reference
- 996-73301, 992-73401 EUDAMED992-73401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987481164819 EUDAMED
- Basic UDI-DI
- 49874814987481164802UR 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 Total Ketone Bodies 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 | 49874814987481164802UR | 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 462a3c1a-392b-4078-abf1-9b129f1aca1d 61 fields · synced Oct 5, 2026