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Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2107E-24Ref S2107E-48
Identity
- Trade Name
- Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Carbohydrate antigen 19-9 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2107E-24 EUDAMEDS2107E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792701243 EUDAMED06955792701236 EUDAMED
- Basic UDI-DI
- B-06955792701243 EUDAMEDB-06955792701236 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General 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 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-06955792701243 | 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 9f97eaa5-48dc-49b8-a291-9803dc89f650 61 fields · synced Oct 6, 2026
- EUDAMED 37063700-30f5-48b3-9086-7f2cee8b01e5 61 fields · synced May 19, 2026