Skip to content

Orbis Prestige Accelerator Free Blue

by Hartalega NGC Sdn. Bhd. Malaysia EUDAMED

Ref R298620Model Nitrile Powder Free Examination Gloves EMDN T01020204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100777HNGCTFMD005CQC Basic UDI-DIDate25 Mar 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  • Withdrawn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 Examination Gloves
Model / Reference
Nitrile Powder Free Examination Gloves, R298620
Primary DI / UDI-DI
19551017620951
Basic UDI-DI
955100777HNGCTFMD005CQC
Unit of Use DI
09551017620954
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Finland

Manufacturer details

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

Other devices from Hartalega Ngc Sdn. Bhd.

See all devices from Hartalega Ngc Sdn. Bhd. →

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 daeb3869-e965-4079-bb5b-b1128e60cce2 61 fields · synced 24 Oct 2026