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Coronavirus Ag Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCCOV-502a-NN Ref GCCOV-502a
Identity
- Trade Name
- Coronavirus Ag Rapid Test Cassette (Swab) EUDAMED
- Device Name
- Coronavirus Ag Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- GCCOV-502a-NN EUDAMEDGCCOV-502a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCOV-502a-NNAM EUDAMEDD-GCCOV-502a4A EUDAMED
- Basic UDI-DI
- B-GCCOV-502a-NNAM EUDAMEDB-GCCOV-502a4A EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Coronavirus Ag Rapid Test Cassette (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — 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-GCCOV-502a-NNAM | 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 97e1243e-912c-4fc3-a758-040db5ce90d6 61 fields · synced Oct 6, 2026
- EUDAMED ee77c7b9-6829-4489-af9b-9720ce1d6f51 61 fields · synced May 18, 2026