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Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva))
EUDAMEDClass IVD General (EU MDR)
Ref L031-125U5
Identity
- Trade Name
- Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva)) EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) EUDAMED
- Model / Reference
- L031-125U5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756493820 EUDAMED
- Basic UDI-DI
- B-06921756493820 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva)) by Acon Biotech (Hangzhou) 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-06921756493820 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 2536aa88-4879-4ee3-9653-ebe19251a680 61 fields · synced Jun 18, 2026