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Cystatin C Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref 5M15C2-25-EU, 5M15C2-50-EU
Identity
- Trade Name
- Cystatin C Test (FIA) EUDAMED
- Device Name
- Cystatin C Test (FIA) EUDAMED
- Model / Reference
- 5M15C2-25-EU, 5M15C2-50-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5M15C2Z6 EUDAMED
- Basic UDI-DI
- B-5M15C2Z6 EUDAMED
- EMDN Code
- W0102160199 SPECIFIC PROTEINS RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
Cystatin C Test (FIA) by Xiamen Boson Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-5M15C2Z6 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 2266e382-8a5f-472a-bf2c-ad73970ec6f1 61 fields · synced Jul 20, 2026
- EUDAMED 2266e382-8a5f-472a-bf2c-ad73970ec6f1-1 61 fields · synced Jun 10, 2026