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Gloveon Coats Nitrile (Bbraun)

by Hartalega NGC Sdn. Bhd. Malaysia EUDAMED

Ref CTS121MMModel Nitrile Powder Free Examination Gloves with Colloidal Oatmeal EMDN T01020204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100777HNGCTFMD007XJ Basic UDI-DIDate18 Feb 2025RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Nitrile Powder Free Examination Gloves
Model / Reference
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal, CTS121MM
Primary DI / UDI-DI
19551017625710
Basic UDI-DI
955100777HNGCTFMD007XJ
Unit of Use DI
09551017625713
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000010459
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Hartalega Ngc Sdn. Bhd.

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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 cb60955f-b8f1-40ec-bd3c-3a73e6bd7393 61 fields · synced 24 Oct 2026