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Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref L031-118W5Ref L031-118N5Ref L031-118Y5Ref L031-118R5
Identity
- Trade Name
- Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) EUDAMEDFlowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) EUDAMED
- Device Name
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) EUDAMEDFlowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) EUDAMED
- Model / Reference
- L031-118W5 EUDAMEDL031-118N5 EUDAMEDL031-118Y5 EUDAMEDL031-118R5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-L031-118W5MV EUDAMEDD-L031-118N5M2 EUDAMEDD-L031-118Y5N3 EUDAMEDD-L031-118R5ME EUDAMED
- Basic UDI-DI
- B-L031-118W5MV EUDAMEDB-L031-118N5M2 EUDAMEDB-L031-118Y5N3 EUDAMEDB-L031-118R5ME EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDNorthern Ireland EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing) by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD devices for self-testing — 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-L031-118W5MV | Class IVD devices for self-testing | 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 (4)
- EUDAMED 05536677-4868-4267-862b-64ed990409b8 61 fields · synced Jul 29, 2026
- EUDAMED ac1de877-dbc9-4716-87c3-ca860b69d6a5 61 fields · synced May 17, 2026
- EUDAMED b2464fdf-3b6c-4416-a878-a10879039caa 61 fields · synced May 18, 2026
- EUDAMED b600d6c5-5230-41d3-afae-3db77efb97df 61 fields · synced May 19, 2026