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Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2059E-100Ref S2059E-25Ref S2059E-200Ref S2059E-75
Identity
- Device Name
- Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2059E-100 EUDAMEDS2059E-25 EUDAMEDS2059E-200 EUDAMEDS2059E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740358 EUDAMED06955792740327 EUDAMED06955792740372 EUDAMED06955792740341 EUDAMED
- Basic UDI-DI
- B-06955792740358 EUDAMEDB-06955792740327 EUDAMEDB-06955792740372 EUDAMEDB-06955792740341 EUDAMED
- EMDN Code
- W0102030116 SQUAMOUS CELL CARCINOMA ANTIGEN 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
Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit 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-06955792740358 | 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 ee1878b0-6d55-4606-8d4b-53039c627251 61 fields · synced Jul 25, 2026
- EUDAMED c7535aaf-b748-493a-81a6-9d31566d6633 61 fields · synced May 17, 2026
- EUDAMED b428d310-776f-4842-a4e4-ed4bfa1e5d43 61 fields · synced May 18, 2026
- EUDAMED ff329637-7ced-4caa-a8ff-e9fae26a205c 61 fields · synced May 19, 2026