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Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCFCRA-545a
Identity
- Trade Name
- Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) EUDAMED
- Device Name
- Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) EUDAMED
- Model / Reference
- GCFCRA-545a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCFCRA-545aWP EUDAMEDD-GCFCRA-545aHG7E EUDAMED
- Basic UDI-DI
- B-GCFCRA-545aWP EUDAMEDB-GCFCRA-545aHG7E EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105090699 OTHER MULTIPLE PATHOGENS - 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
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — 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-GCFCRA-545aWP | 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 (2)
- EUDAMED 84f6bd06-8e61-4c41-b7d2-debf4d82d525 61 fields · synced Oct 6, 2026
- EUDAMED 13b2c5dd-33c2-48a6-8312-de825b49ef63 61 fields · synced May 18, 2026