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Dona Sensitive

by Terang Nusa (Malaysia) Sdn. Bhd. 6 variants

Ref 9021-9.5, 9021-7.5, 9021-5.5, 9021-5.0, 9021-9.0

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955507611000GF Basic UDI-DI Date19 Nov 2024RegisteredStatusActive

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  • Withdrawn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 Latex Surgical Powdered Glove
Model / Reference
9021-9.5, 9021-7.5, 9021-5.5, 9021-5.0, 9021-9.0
Primary DI / UDI-DI
09555076120097, 09555076120059, 09555076120011, 09555076120004, 09555076120080
Basic UDI-DI
955507611000GF
EMDN Code
T01010101 Powdered latex surgical gloves
Device Class
Class IIa
EU 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