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Rapid COVID-19 (Antigen) Self-Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref GCCOV-502a-H5OGERef GCCOV-502a-H20OGERef GCCOV-502a-H8OGERef GCCOV-502a-H7OGERef GCCOV-502a-H1OGERef GCCOV-502a-H25OGERef GCCOV-502a-H10OGE
Identity
- Trade Name
- Rapid COVID-19 (Antigen) Self-Test EUDAMED
- Device Name
- Rapid COVID-19 (Antigen) Self-Test EUDAMED
- Model / Reference
- GCCOV-502a-H5OGE EUDAMEDGCCOV-502a-H20OGE EUDAMEDGCCOV-502a-H8OGE EUDAMEDGCCOV-502a-H7OGE EUDAMEDGCCOV-502a-H1OGE EUDAMEDGCCOV-502a-H25OGE EUDAMEDGCCOV-502a-H10OGE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCOV-502a-H5OGEFK EUDAMEDD-GCCOV-502a-H20OGET8 EUDAMEDD-GCCOV-502a-H8OGEG8 EUDAMEDD-GCCOV-502a-H7OGEFZ EUDAMEDD-GCCOV-502a-H1OGEEP EUDAMEDD-GCCOV-502a-H25OGEUB EUDAMEDD-GCCOV-502a-H10OGESV EUDAMED
- Basic UDI-DI
- B-GCCOV-502a-H5OGEFK EUDAMEDB-GCCOV-502a-H20OGET8 EUDAMEDB-GCCOV-502a-H8OGEG8 EUDAMEDB-GCCOV-502a-H7OGEFZ EUDAMEDB-GCCOV-502a-H1OGEEP EUDAMEDB-GCCOV-502a-H25OGEUB EUDAMEDB-GCCOV-502a-H10OGESV EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Rapid COVID-19 (Antigen) Self-Test by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD devices for self-testing — 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-502a-H5OGEFK | Class IVD devices for self-testing | 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 (7)
- EUDAMED 66ea02b8-eb0e-4eef-b1ae-23af983a52f8 61 fields · synced Oct 6, 2026
- EUDAMED e8bba865-d735-4076-8c5d-c51d5a72bf4b 61 fields · synced May 16, 2026
- EUDAMED 44b0ac4d-ad88-4a14-910e-3cd8213fb8d5 61 fields · synced May 17, 2026
- EUDAMED 1dca90ff-4ab0-4cfb-87a3-81a1c9af3d65 61 fields · synced May 17, 2026
- EUDAMED 9f8e6305-6197-4200-8d9a-63c7ef59c384 61 fields · synced May 17, 2026
- EUDAMED 7b865a49-90de-47c4-a29d-9cd3209ce623 61 fields · synced May 18, 2026
- EUDAMED 29652c2a-8137-4892-87ee-233a3e33c483 61 fields · synced May 19, 2026