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Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR)
EUDAMEDClass IVD General (EU MDR)
Ref AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E
Identity
- Device Name
- Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69509960APA01PVQB EUDAMED
- Basic UDI-DI
- B-69509960APA01PVQB EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed…
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-69509960APA01PVQB | 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 d87909d9-13c7-47af-a941-10ed50792fab-1 61 fields · synced Jun 20, 2026
- EUDAMED d87909d9-13c7-47af-a941-10ed50792fab-2 61 fields · synced Jun 20, 2026