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Gammex Non-Latex PI

by Ansell Healthcare Europe NV EUDAMED

Active European Union

Ref 340056075 7.5

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414566GNLPI340020687G Basic UDI-DIDate5 Mar 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  • Withdrawn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
Polyisoprene Surgical Gloves
Model / Reference
340056075 7.5
Primary DI / UDI-DI
15414566560755
Basic UDI-DI
5414566GNLPI340020687G
EMDN Code
T01010203 Polyisopren surgical gloves
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