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Flowflex

by Acon Biotech (Hangzhou) Co., Ltd. 113 variants

Ref L031-10445

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6977L03110445RD Basic UDI-DI Date17 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)
Flowflex Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)
Model / Reference
L031-10445
Primary DI / UDI-DI
D-6977L03110445RD, D-L031-10445HU
Basic UDI-DI
B-6977L03110445RD, B-L031-10445HU
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class IVD General
EU market of registration
Poland
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000006977
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Acon Biotech (Hangzhou) Co., Ltd.

See all devices from Acon Biotech (Hangzhou) Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No