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Dispo Nitrile Pf Sky Blue

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref PRE0102012, PRE0102009, PRE0102011

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955760101940H5 Basic UDI-DIDate17 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Nitrile Examination Powder Free Gloves
Model / Reference
PRE0102012, PRE0102009, PRE0102011
Primary DI / UDI-DI
09551004375935, 09551004375966, 09551004375942
Basic UDI-DI
955760101940H5
EMDN Code
T01020204, T010201
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000009690
Authorised representative
Ulma International GmbH DE-AR-000010015

Other devices from Top Glove Sdn. Bhd.

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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