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Cancer Antigen 125 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2008E-75Ref S2008E-100Ref S2008E-150Ref S2008E-50Ref S2008E-200
Identity
- Device Name
- Cancer Antigen 125 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2008E-75 EUDAMEDS2008E-100 EUDAMEDS2008E-150 EUDAMEDS2008E-50 EUDAMEDS2008E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736726 EUDAMED06955792736733 EUDAMED06955792736740 EUDAMED06955792736719 EUDAMED06955792736757 EUDAMED
- Basic UDI-DI
- B-06955792736726 EUDAMEDB-06955792736733 EUDAMEDB-06955792736740 EUDAMEDB-06955792736719 EUDAMEDB-06955792736757 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
Cancer Antigen 125 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-06955792736726 | 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 (5)
- EUDAMED 5d9b8db3-eaf6-45a8-8d9f-7d927ff2c4c5 61 fields · synced Jul 28, 2026
- EUDAMED 76383f2e-030e-427f-9fb7-1f397c65ad41 61 fields · synced May 17, 2026
- EUDAMED 06da677f-f58d-4da8-ba45-d610d1387fb0 61 fields · synced May 17, 2026
- EUDAMED b8eb9407-1efe-40d0-9afa-c3bf89c8fa47 61 fields · synced May 18, 2026
- EUDAMED 6c4217c7-614c-42ec-9164-ec018b793943 61 fields · synced May 19, 2026