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Fusione

by Terang Nusa (Malaysia) Sdn. Bhd. 8 variants

Ref FSN-507611543

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955507611560HS Basic UDI-DI 09555076115437UDI-DIDate5 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Polyisoprene Surgical Powder Free
Model / Reference
FSN-507611543
Primary DI / UDI-DI
09555076115437
Basic UDI-DI
955507611560HS
EMDN Code
T01010203 Polyisopren surgical gloves
Device Class
Class IIa
EU 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

  • 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