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Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref GECEA-402aRef GECEA-401a
Identity
- Trade Name
- Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GECEA-402a EUDAMEDGECEA-401a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GECEA-402aPK EUDAMEDD-OGGECEA-402aBG EUDAMED
- Basic UDI-DI
- B-GECEA-402aPK EUDAMEDB-OGGECEA-402aBG EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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 Cassette (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-GECEA-402aPK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 22154d94-fbe8-4359-b9cc-582f7ff48934 61 fields · synced Oct 6, 2026
- EUDAMED 40547b7a-f10d-4e16-8dfb-ce406d1d5003 61 fields · synced May 18, 2026