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Vital

by Terang Nusa (Malaysia) Sdn. Bhd. Malaysia EUDAMED

Ref 8300-75

EMDN T01010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955507611080H7 Basic UDI-DIDate21 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Latex Surgical Powder Free Glove
Model / Reference
8300-75
Primary DI / UDI-DI
09555076125252
Basic UDI-DI
955507611080H7
EMDN Code
T01010102 Non-powdered latex surgical gloves
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
MY-MF-000023462
Authorised representative
Ulma International GmbH DE-AR-000010015

Other devices from Terang Nusa (Malaysia) Sdn. Bhd.

See all devices from Terang Nusa (Malaysia) Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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 71bdb847-fe96-40a2-867e-d2005671e7a9 61 fields · synced 22 Oct 2026