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Influenza A&B control swab

by NanoEntek, Inc.

Ref FIC-FLSWModel Influenza A&B control swab

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809317540726 Basic UDI-DI 08809317540726UDI-DIDate13 Sep 2022RegisteredStatusActive

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  • Withdrawn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
Fic-Flsw
Model / Reference
Influenza A&B control swab, FIC-FLSW
Primary DI / UDI-DI
08809317540726
Basic UDI-DI
B-08809317540726
EMDN Code
W0105080804 Other virology controls - inf.imm.
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000021903
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No