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CH50 Calibrator Set
EUDAMEDClass B (EU MDR)
Ref 993-43901Model 993-40601, 999-40701, 993-43901, 993-44001
Identity
- Trade Name
- CH50 Calibrator Set EUDAMED
- Device Name
- Autokit CH50 Set, CH50 Calibrator Set, Complement Control Set EUDAMED
- Model / Reference
- 993-40601, 999-40701, 993-43901, 993-44001 EUDAMED993-43901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987481164857 EUDAMED
- Basic UDI-DI
- 49874814987481164833V4 EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
CH50 Calibrator 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 | 49874814987481164833V4 | 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 a1b25c88-1f5f-417a-81b2-4c932198af08 61 fields · synced Jun 18, 2026