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25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2001E-200Ref S2001E-25Ref S2001E-100Ref S2001E-75
Identity
- Device Name
- 25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2001E-200 EUDAMEDS2001E-25 EUDAMEDS2001E-100 EUDAMEDS2001E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736337 EUDAMED06955792736283 EUDAMED06955792736313 EUDAMED06955792736306 EUDAMED
- Basic UDI-DI
- B-06955792736337 EUDAMEDB-06955792736283 EUDAMEDB-06955792736313 EUDAMEDB-06955792736306 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D 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
25-Hydroxy Vitamin D 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-06955792736337 | 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 (4)
- EUDAMED 98dd3d0a-8cf9-44b8-8db4-a1a949a1353f 61 fields · synced Aug 3, 2026
- EUDAMED 9bacfaae-a120-4e7d-ae22-201d0c1c64ac 61 fields · synced May 18, 2026
- EUDAMED f0057da6-e69e-42f0-b2a6-97088dea5ced 61 fields · synced May 18, 2026
- EUDAMED 3e8a6b8b-0568-471a-827e-058a6d1f8c2c 61 fields · synced May 18, 2026