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Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2007E-100Ref S2007E-150Ref S2007E-200
Identity
- Device Name
- Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2007E-100 EUDAMEDS2007E-150 EUDAMEDS2007E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736672 EUDAMED06955792736689 EUDAMED06955792736696 EUDAMED
- Basic UDI-DI
- B-06955792736672 EUDAMEDB-06955792736689 EUDAMEDB-06955792736696 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
Cancer Antigen 15-3 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-06955792736672 | 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 a08ff19e-1581-4ecf-8f65-53bf0eb304e5 61 fields · synced Jul 18, 2026
- EUDAMED b8e0aaca-c484-4039-a985-3351306e92ad 61 fields · synced May 18, 2026
- EUDAMED ab6b5157-40aa-4e64-a4b0-50f886480b7e 61 fields · synced May 18, 2026
- EUDAMED ff8b580b-bed4-48e0-8370-3d9a8f49c8e5 61 fields · synced Jul 18, 2026