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Dona Sensitive

by Terang Nusa (Malaysia) Sdn. Bhd. EUDAMED

Active European Union

Ref 9021-6.0

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955507611000GF Basic UDI-DIDate19 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Sterile Latex Surgical Powdered Glove
Model / Reference
9021-6.0
Primary DI / UDI-DI
09555076120028
Basic UDI-DI
955507611000GF
EMDN Code
T01010101 Powdered latex surgical gloves
Device Class
Class IIa
Market of Registration
Czechia

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

  • 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