← Back to catalogue
Carcinoembryonic Antigen Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2011E-150Ref S2011E-75Ref S2011E-100Ref S2011E-25Ref S2011E-200
Identity
- Device Name
- Carcinoembryonic Antigen Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2011E-150 EUDAMEDS2011E-75 EUDAMEDS2011E-100 EUDAMEDS2011E-25 EUDAMEDS2011E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736924 EUDAMED06955792736900 EUDAMED06955792736917 EUDAMED06955792736887 EUDAMED06955792736931 EUDAMED
- Basic UDI-DI
- B-06955792736924 EUDAMEDB-06955792736900 EUDAMEDB-06955792736917 EUDAMEDB-06955792736887 EUDAMEDB-06955792736931 EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC 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
Carcinoembryonic Antigen 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-06955792736924 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 98261db4-515e-4dd4-809a-73da001e8435 61 fields · synced Jul 16, 2026
- EUDAMED 623d7451-c2dc-400b-ab13-096a6c73f9b7 61 fields · synced May 17, 2026
- EUDAMED c3a65df5-18b5-40a6-a921-07b3b3f9d398 61 fields · synced May 17, 2026
- EUDAMED 34694c4c-034e-4264-b013-41994c838a84 61 fields · synced May 18, 2026
- EUDAMED b125ad85-8039-4fd8-8ae0-7e7c6fc147ae 61 fields · synced May 18, 2026