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Vitamin B12 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2156E-25Ref S2156E-75Ref S2156E-100Ref S2156E-150Ref S2156E-200
Identity
- Device Name
- Vitamin B12 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2156E-25 EUDAMEDS2156E-75 EUDAMEDS2156E-100 EUDAMEDS2156E-150 EUDAMEDS2156E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743144 EUDAMED06955792743168 EUDAMED06955792743175 EUDAMED06955792743182 EUDAMED06955792743199 EUDAMED
- Basic UDI-DI
- B-06955792743144 EUDAMEDB-06955792743168 EUDAMEDB-06955792743175 EUDAMEDB-06955792743182 EUDAMEDB-06955792743199 EUDAMED
- EMDN Code
- W0102070204 VITAMIN B12 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
Vitamin B12 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-06955792743144 | 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 (5)
- EUDAMED 51bc6dea-52fc-44a1-9549-275a6636505e 61 fields · synced Jul 28, 2026
- EUDAMED dc286a84-69f4-430c-8cfa-192acf7caab3 61 fields · synced May 17, 2026
- EUDAMED b3c25a2e-4576-4a88-92f9-7270bcb19369 61 fields · synced May 18, 2026
- EUDAMED 9eee6bb6-4854-46cf-9af1-f0bea283613b 61 fields · synced May 18, 2026
- EUDAMED 7676bd4b-4975-4286-88ec-efa7e1ae24ce 61 fields · synced May 19, 2026