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COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCCOV(B117)-525a
Identity
- Trade Name
- COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) EUDAMED
- Device Name
- COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) EUDAMED
- Model / Reference
- GCCOV(B117)-525a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCOV(B117)-525aKE EUDAMEDD-GCCOV(B117)-525aHGE5 EUDAMED
- Basic UDI-DI
- B-GCCOV(B117)-525aKE EUDAMEDB-GCCOV(B117)-525aHGE5 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
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) by Zhejiang Orient Gene Biotech 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-GCCOV(B117)-525aKE | 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 404d35db-5707-465d-bf1b-c64d04eb0430 61 fields · synced Oct 6, 2026
- EUDAMED b48a7083-49f4-4ba5-9d9d-ecc42da271f5 61 fields · synced May 19, 2026