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Cancer Antigen CA 72-4 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2009E-50Ref S2009E-25Ref S2009E-200Ref S2009E-75
Identity
- Device Name
- Cancer Antigen CA 72-4 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2009E-50 EUDAMEDS2009E-25 EUDAMEDS2009E-200 EUDAMEDS2009E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736771 EUDAMED06955792736764 EUDAMED06955792736818 EUDAMED06955792736788 EUDAMED
- Basic UDI-DI
- B-06955792736771 EUDAMEDB-06955792736764 EUDAMEDB-06955792736818 EUDAMEDB-06955792736788 EUDAMED
- EMDN Code
- W0102030105 CANCER ANTIGEN 72-4 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 CA 72-4 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-06955792736771 | 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 6d925108-a0cd-4476-ac5d-52ed4a8595b9 61 fields · synced Jul 26, 2026
- EUDAMED c133c29f-6826-4724-934b-339cb2770dfe 61 fields · synced May 18, 2026
- EUDAMED 04aafd2e-f9b9-4b36-b848-a1a712beb71e 61 fields · synced May 18, 2026
- EUDAMED 4b7a50ff-46b9-4715-a38b-4ff74225afd5 61 fields · synced May 18, 2026