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Hiven

by Marginum Oy

Ref 06429810994004

Expiring European Union

CE MDR

Valid until

16 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number64298109943000X8 Basic UDI-DI 06429810994004UDI-DIDate24 Sep 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI25/00000050 Expiring Expires in 319 days

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    16 Sep 2025
    Expires
    16 Sep 2027
    Valid from
    17 Sep 2025

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Aspirate Tissue Detector
Model / Reference
06429810994004
Primary DI / UDI-DI
06429810994004
Basic UDI-DI
64298109943000X8
Direct Marketing DI
06429810994004
EMDN Code
Z12109099 Various neurology and neurosurgery instruments - other
Device Class
Class IIb
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000030256

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No