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Rapid Flu A&B+RSV+Adeno Antigen Test
EUDAMEDClass C (EU MDR)
Ref GCFRA-T525a-DRH5Model GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20
Identity
- Trade Name
- Rapid Flu A&B+RSV+Adeno Antigen Test EUDAMED
- Device Name
- Rapid Flu A&B+RSV+Adeno Antigen Test EUDAMED
- Model / Reference
- GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20 EUDAMEDGCFRA-T525a-DRH5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996004091 EUDAMED
- Basic UDI-DI
- 69509960GCFRA-T525aDRH3A EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Rapid Flu A&B+RSV+Adeno Antigen Test by Zhejiang Orient Gene Biotech Co., Ltd — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69509960GCFRA-T525aDRH3A | 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 (1)
- EUDAMED 41f3480a-b866-4dad-8e89-827b126c1ab9 61 fields · synced Oct 5, 2026