← Back to catalogue
Rapid COVID-19 (Antigen) Self-Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref GCCOV-502a-H3OGE
Identity
- Trade Name
- Rapid COVID-19 (Antigen) Self-Test EUDAMED
- Device Name
- Rapid COVID-19 (Antigen) Self-Test EUDAMED
- Model / Reference
- GCCOV-502a-H3OGE EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCCOV-502a-H3OGEF5 EUDAMED
- Basic UDI-DI
- B-GCCOV-502a-H3OGEF5 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 is a fast, user-friendly, and accurate diagnostic device for COVID-19 testing. Using an antigen-based test, this self-test kit allows users to quickly identify whether they have been infected with SARS-CoV-2 or not.
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-H3OGEF5 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
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 (1)
- EUDAMED ed9fb672-630b-4f55-ac12-b0fdbf6f95d6 61 fields · synced Oct 7, 2026