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Asap

by ASAP International Sdn. Bhd. Malaysia EUDAMED

Ref 10411Model Single Use Examination Gloves

EMDN T010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955589090ASAPPPL5E Basic UDI-DIDate9 Jun 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
Latex Powdered Examination Gloves
Model / Reference
Single Use Examination Gloves, 10411
Primary DI / UDI-DI
09555890901278
Basic UDI-DI
955589090ASAPPPL5E
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
MY-MF-000004500
Authorised representative
ASAP Innovations Ltd. IE-AR-000002548

Other devices from ASAP International Sdn. Bhd.

See all devices from ASAP International Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (12)
  • Sterile: No
  • 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 307ec9a4-60d1-49e4-bb99-f962ad983eea 61 fields · synced 22 Oct 2026