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Latex Powdered Examination Gloves

by ASAP International Sdn. Bhd. EUDAMED

Active European Union

Ref 10412, 10414Model Single Use Examination Gloves

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955589090ASAPPPL5E Basic UDI-DIDate9 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Latex Powdered Examination Gloves
Model / Reference
Single Use Examination Gloves, 10412, 10414
Primary DI / UDI-DI
09555890901285, 09555890901308
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
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from ASAP International Sdn. Bhd.

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Properties

  • 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