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Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2010E-200Ref S2010E-75Ref S2010E-150Ref S2010E-50
Identity
- Device Name
- Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2010E-200 EUDAMEDS2010E-75 EUDAMEDS2010E-150 EUDAMEDS2010E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736870 EUDAMED06955792736849 EUDAMED06955792736863 EUDAMED06955792736832 EUDAMED
- Basic UDI-DI
- B-06955792736870 EUDAMEDB-06955792736849 EUDAMEDB-06955792736863 EUDAMEDB-06955792736832 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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
Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792736870 | 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 7c3e4dc9-b152-4b59-b8ea-ab474c3cbb67 61 fields · synced Jul 20, 2026
- EUDAMED abd3af7a-6e4d-48b4-be71-6707dd9c8e3f 61 fields · synced May 18, 2026
- EUDAMED f7a1995a-7c6e-4f3a-965b-06db0d577e66 61 fields · synced May 18, 2026
- EUDAMED 1e92cebf-37a1-4f18-86e1-49970ed9bd33 61 fields · synced May 18, 2026