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Carbohydrate antigen 125 Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2108E-24Ref S2108E-48
Identity
- Device Name
- Carbohydrate antigen 125 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2108E-24 EUDAMEDS2108E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792741065 EUDAMED06955792741072 EUDAMED
- Basic UDI-DI
- B-06955792741065 EUDAMEDB-06955792741072 EUDAMED
- EMDN Code
- W0102030106 CANCER ANTIGEN 125 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 125 Assay Kit (Chemiluminescent Immunoassay) 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-06955792741065 | 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 88b18213-46f5-4d1f-9502-230e9cddab58 61 fields · synced Jul 8, 2026
- EUDAMED 66139194-4595-4be5-81e1-ac7278748f7e 61 fields · synced May 18, 2026