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Encore Non-Latex PI Hybrid

by Ansell Healthcare Europe NV EUDAMED

Active European Union

Ref 340105055

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414566GEPIHYB340UL Basic UDI-DIDate11 Jan 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Gammex PI Hybrid
Model / Reference
340105055
Primary DI / UDI-DI
15414566050553
Basic UDI-DI
5414566GEPIHYB340UL
EMDN Code
T01010299 Synthetic surgical gloves - other
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000691

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Properties

Show properties
  • Sterile
Other properties (12)
  • 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