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SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref /Ref SARS-CoV-2/Flu A+B/RSV Antigen cassette
Identity
- Trade Name
- SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test EUDAMED
- Device Name
- SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test EUDAMED
- Model / Reference
- / EUDAMEDSARS-CoV-2/Flu A+B/RSV Antigen cassette EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935091671966 EUDAMEDD-693757990638QW EUDAMED
- Basic UDI-DI
- B-06935091671966 EUDAMEDB-693757990638QW EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test by Qingdao Hightop Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06935091671966 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016890
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 55eb512b-90c6-4141-b4a2-de7291762adb 61 fields · synced Jul 12, 2026
- EUDAMED 9afe4699-3816-48ba-9563-103ed75b9352 61 fields · synced Jul 12, 2026