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Carcinoembryonic Antigen Rapid Test Strip (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref GECEA-401a
Identity
- Trade Name
- Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GECEA-401a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-OGGECEA-401aBD EUDAMEDD-GECEA-401aPG EUDAMED
- Basic UDI-DI
- B-OGGECEA-401aBD EUDAMEDB-GECEA-401aPG EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Carcinoembryonic Antigen Rapid Test Strip (Whole Blood +2 more) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — 3…
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-OGGECEA-401aBD | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9ca4c48a-2d06-4627-8bd3-8f249d9db694 61 fields · synced Oct 6, 2026
- EUDAMED c986b5b8-5338-4b10-9e33-3c853883a249 61 fields · synced May 17, 2026