Identity
- Trade Name
- Ketone Body Calibrator 300 EUDAMED
- Device Name
- Ketone Body Calibrator 300 EUDAMED
- Model / Reference
- 993-73791 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481164823 EUDAMED
- Basic UDI-DI
- 498748114987481164823ZS EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - 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
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
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
Ketone Body Calibrator 300 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 | 498748114987481164823ZS | 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 (2)
- EUDAMED eea2e68a-0c1b-42fc-a797-783055ea0adb 61 fields · synced Jun 18, 2026
- EUDAMED 15dd7b94-bbea-4b6e-b646-069d63f4f525 61 fields · synced Jun 18, 2026