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COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCFCRA-T525aRef 3022501Ref GCFC-T502a-H5Model GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20
Identity
- Trade Name
- COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) EUDAMEDCOVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab) EUDAMEDCOVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) EUDAMED
- Device Name
- COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) EUDAMEDCOVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab) EUDAMEDCOVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- GCFCRA-T525a EUDAMED3022501 EUDAMEDGCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20 EUDAMEDGCFC-T502a-H5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCFCRA-T525a8X EUDAMED69743840313604 EUDAMED06950996002318 EUDAMEDD-GCFCRA-T525aHGTK EUDAMED
- Basic UDI-DI
- B-GCFCRA-T525a8X EUDAMEDB-69743840313604 EUDAMED69509960GCFC-T502a-HSQ EUDAMEDB-GCFCRA-T525aHGTK EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-GCFCRA-T525a8X | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-GCFCRA-T525a8X | 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 (4)
- EUDAMED 3d1d5b22-efa5-4395-ba6e-e408858d5b92 61 fields · synced Oct 6, 2026
- EUDAMED 197156ce-0910-412c-8a0d-156a2abb8c0e 61 fields · synced May 18, 2026
- EUDAMED 714b990d-0b1e-4658-b756-cb73eba81d3e 61 fields · synced May 18, 2026
- EUDAMED 0527ccaf-21f5-4458-bcb1-917d460d368f 61 fields · synced May 19, 2026