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sempermed skin² white (featuring velvet XP white)

by HARPS Investment Asia Pte. Ltd. EUDAMED

Active European Union

Ref 3000016098Model Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, white

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9001570N*F-035WH-N-3WF Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, white, 3000016098
Primary DI / UDI-DI
09001570553164
Basic UDI-DI
9001570N*F-035WH-N-3WF
Unit of Use DI
09001570542489
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
SG-MF-000001645
Authorised representative
HARPS Europe GmbH AT-AR-000040870

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Properties

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