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Colector de Flujo Microcapilar (MFC)

by Seinda Biomedical Corporation 4 variants

Ref S04A2.2-050Model S04A2.2, S04E1.1

Active European Union

CE IVDR

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/IVDR Number697297646S04VJ Basic UDI-DI 06972976461182UDI-DIDate30 May 2025RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Micro-Capillary Fluid Collector (MFC)
Model / Reference
S04A2.2, S04E1.1, S04A2.2-050
Primary DI / UDI-DI
06972976461182
Basic UDI-DI
697297646S04VJ
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000047055
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Seinda Biomedical Corporation

See all devices from Seinda Biomedical Corporation →

Properties

  • Near-Patient Testing
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No