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INFANT-Guardian

by K2 Medical Systems United Kingdom EUDAMED

Ref INFANT-Guardian EMDN Z12080392

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506047038InfantGuardianX7 Basic UDI-DIDate13 Jul 2022RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
K2 INFANT-Guardian®
Model / Reference
INFANT-Guardian
Primary DI / UDI-DI
05060470380083
Basic UDI-DI
506047038InfantGuardianX7
EMDN Code
Z12080392 Various childbirth support and maternal assistance instruments - medical device software
Device Class
Class IIa
Special Device Type
Software

Manufacturer details

EUDAMED SRN
GB-MF-000019924
Authorised representative
Picis Clinical Solutions, S.A. ES-AR-000019764

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 338ffe07-bae5-4803-8632-58a495c3e2c6 61 fields · synced 24 Oct 2026