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Fusione Duplex

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

Ref FSD-507611946

EMDN T01010203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955507611560HS Basic UDI-DIDate5 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile Polyisoprene Surgical Powder Free
Model / Reference
FSD-507611946
Primary DI / UDI-DI
09555076119466
Basic UDI-DI
955507611560HS
EMDN Code
T01010203 Polyisopren surgical gloves
Device Class
Class IIa
Market of Registration
Germany

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
Other properties (12)
  • 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 09555076119466|955507611560HS 61 fields · synced 24 Oct 2026