← Back to catalogue
GENEDIA W COVID-19 Ag
EUDAMEDClass IVD General (EU MDR)
Ref 643KRef 643GRef 643G-S
Identity
- Trade Name
- GENEDIA W COVID-19 Ag EUDAMED
- Device Name
- GENEDIA W COVID-19 Ag EUDAMED
- Model / Reference
- 643K EUDAMED643G EUDAMED643G-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134601081 EUDAMED08806134601067 EUDAMED08806134664321 EUDAMED08806134664840 EUDAMED08806134664345 EUDAMED08806134601043 EUDAMED08806134664338 EUDAMED
- Basic UDI-DI
- B-08806134601081 EUDAMEDB-08806134601067 EUDAMEDB-08806134664321 EUDAMEDB-08806134664840 EUDAMEDB-08806134664345 EUDAMEDB-08806134601043 EUDAMEDB-08806134664338 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
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GENEDIA W COVID-19 Ag by GC Medical Science Corporation — 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-08806134601081 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GC Medical Science Corporation
- EUDAMED SRN
- KR-MF-000015840
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (7)
- EUDAMED fc69fa0a-c3dc-49be-b3f0-753aa6323563 61 fields · synced Aug 3, 2026
- EUDAMED 8f857acf-3bd9-403c-bb74-3780ad3d4a76 61 fields · synced May 17, 2026
- EUDAMED bb6a8221-731b-4155-89cb-9d79d814c8b1 61 fields · synced May 17, 2026
- EUDAMED 6d5e54d9-7066-41dd-921c-b60c71198803 61 fields · synced May 17, 2026
- EUDAMED f28b4851-2cab-49c2-bd99-f881a1d50e0b 61 fields · synced May 17, 2026
- EUDAMED 6f6ca86c-bac1-4d59-adf5-c69a5b2c9278 61 fields · synced May 17, 2026
- EUDAMED 79429c0c-e48b-45d2-a8e4-0aaf901525de 61 fields · synced May 18, 2026