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sigvaris FIX Lotion Adhésive

by Ultrana GmbH Germany EUDAMED

Ref 350463 EMDN H900199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP060720732046 Basic UDI-DIDate9 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
HaftFIX Adhäsionslotion
Model / Reference
350463
Primary DI / UDI-DI
04011368073908
Basic UDI-DI
PP060720732046
Direct Marketing DI
04011368073908
EMDN Code
H900199 Tissue adhesives - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000006110

Other devices from Ultrana GmbH

See all devices from Ultrana GmbH →

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 22086774-e0fc-438b-befa-aa77717e05d5 61 fields · synced 23 Oct 2026