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Osteocalcin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2146E-100Ref S2146E-25
Identity
- Device Name
- Osteocalcin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2146E-100 EUDAMEDS2146E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742598 EUDAMED06955792742567 EUDAMED
- Basic UDI-DI
- B-06955792742598 EUDAMEDB-06955792742567 EUDAMED
- EMDN Code
- W0102060311 OSTEOCALCINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Osteocalcin Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792742598 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 7cc17ba9-f61e-46cb-b051-8a46c479875c 61 fields · synced Jul 29, 2026
- EUDAMED 271f4ebb-4109-417d-a6a4-c929a7317fa7 61 fields · synced May 18, 2026