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Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2105E-24Ref S2105E-48
Identity
- Trade Name
- Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2105E-24 EUDAMEDS2105E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792701397 EUDAMED06955792701250 EUDAMED
- Basic UDI-DI
- B-06955792701397 EUDAMEDB-06955792701250 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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 15-3 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-06955792701397 | 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 05864ea3-8453-470a-b1ac-984be9aacc7d 61 fields · synced Jul 31, 2026
- EUDAMED 1a5c206a-a4fe-404b-901b-9ffa2d0f607f 61 fields · synced May 17, 2026