← Back to catalogue
Carcinoembryonic AntigenAssay Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 10 tests/kitRef 100 tests/kitModel 100 tests/kit
Identity
- Trade Name
- Carcinoembryonic AntigenAssay Kit (Immunochromatographic Assay) EUDAMED
- Device Name
- Carcinoembryonic AntigenAssay Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814071 EUDAMED06974986814101 EUDAMED
- Basic UDI-DI
- B-06974986814071 EUDAMEDB-06974986814101 EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 AntigenAssay Kit (Immunochromatographic Assay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974986814071 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 94960618-cf29-4939-95d2-6d342f013970 61 fields · synced Oct 6, 2026
- EUDAMED 120fb8cd-f1be-4b1f-81ec-a1d9a674f284 61 fields · synced May 18, 2026