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COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
EUDAMEDClass C (EU MDR)
Ref GCFC-T502a-H2Model GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20Ref GCFC-T502a-DRRef GCFC-T502a-H7
Identity
- Trade Name
- COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) EUDAMED
- Device Name
- COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20 EUDAMEDGCFC-T502a-H2 EUDAMEDGCFC-T502a-DR EUDAMEDGCFC-T502a-H7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996002295 EUDAMED06950996002271 EUDAMED06950996002325 EUDAMED
- Basic UDI-DI
- 69509960GCFC-T502a-HSQ EUDAMED69509960GCFC-T502a-DRHJ EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69509960GCFC-T502a-HSQ | Class C | 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 (3)
- EUDAMED 522d7bcf-d60e-4472-a81f-cc44fd168357 61 fields · synced Oct 6, 2026
- EUDAMED d6c2ad51-41df-42a4-8281-0c59db09a6c9 61 fields · synced May 18, 2026
- EUDAMED ecfdef6a-c3c0-435b-a1f8-e4ec5703dae8 61 fields · synced May 18, 2026