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Influenza A&B Antigen Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref VILFA-01Ref VILFA-20
Identity
- Trade Name
- Influenza A&B Antigen Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- Influenza A&B Antigen Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- VILFA-01 EUDAMEDVILFA-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080956 EUDAMED06970514080963 EUDAMED
- Basic UDI-DI
- B-06970514080956 EUDAMEDB-06970514080963 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Influenza A&B Antigen Rapid Test (Colloidal Gold) by Genobio Pharmaceutical 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-06970514080956 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 1688dad8-9867-4ef6-b44a-6d89c0a56e8b 61 fields · synced Jul 27, 2026
- EUDAMED ad54e068-ea5c-4d98-9cca-ca4e6efb3d74 61 fields · synced Jul 24, 2026