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Carcinoembryonic Antigen(CEA) Test (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 1001021
Identity
- Device Name
- Carcinoembryonic Antigen(CEA) Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 1001021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979878281252 EUDAMED
- Basic UDI-DI
- B-06979878281252 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
Yes
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 Antigen(CEA) Test (Fluorescence Immunoassay) by Huzhou Jierunxin Biotechnology Co., LTD — 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-06979878281252 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Huzhou Jierunxin Biotechnology Co., LTD
- EUDAMED SRN
- CN-MF-000047637
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED c67f5959-3784-48c4-8945-cc927046f1ec 61 fields · synced Jun 18, 2026