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Influenza A & B Ag Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCFLU(A/B)-502aRef GCFLU(A/B)-502a，GCFLU(A/B)-502Ca Model GCFLU(A/B)-502a, GCFLU(A/B)-502Ca
Identity
- Trade Name
- Influenza A & B Ag Rapid Test Cassette (Swab) EUDAMED
- Device Name
- Influenza A & B Ag Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- GCFLU(A/B)-502a EUDAMEDGCFLU(A/B)-502a, GCFLU(A/B)-502Ca EUDAMEDGCFLU(A/B)-502a，GCFLU(A/B)-502Ca EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996002387 EUDAMEDD-GCFLU(A/B)-5024L EUDAMED
- Basic UDI-DI
- B-06950996002387 EUDAMEDB-GCFLU(A/B)-5024L EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Influenza A & B Ag Rapid 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-06950996002387 | 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 585dbc8d-4d2b-4ecd-854a-4a091df76c6b 61 fields · synced Oct 6, 2026
- EUDAMED 4f87b348-1c2f-4c34-9bc3-89ce1724da29 61 fields · synced May 17, 2026