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Asap

by ASAP International Sdn. Bhd. EUDAMED

Active European Union

Ref 21211, 20964, 20692VB, 20795, 21172, 20791, 20551, 21214, 10444, 20101C-C3, 10441, 20793, 20961, 20693VB, 21213, 20792, 21174, 21215, 30011, 10445, 20554, 20552, 10443Model Single Use Examination Gloves

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955589090ASAPPFN4L Basic UDI-DIDate1 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
Asap
Medical Face Mask
Device Name
Nitrile Powder Free Examination Gloves
Latex Powdered Examination Gloves
Model / Reference
21211, 20964, 20692VB, 20795, 21172, 20791, 20551, 21214, Single Use Examination Gloves, 10444, 20101C-C3, 10441, 20793, 20961, 20693VB, 21213, 20792, 21174, 21215, 30011, 10445, 20554, 20552, 10443
Primary DI / UDI-DI
09555890931947, 09555890917033, 09555890903180, 09555890902350, 09555890930933, 09555890902312, 09555890913783, 09555890931978, 09555890902589, 09555890936324, 09555890902558, 09555890902336, 09555890917002, 09555890903197, 09555890931961, 09555890902329, 09555890930957, 09555890931985, 09555890902046, 09555890902596, 09555890913813, 09555890913790, 09555890902572
Basic UDI-DI
955589090ASAPPFN4L, 955589090ASAPPPL5E, 955589090ASAPFMTG
EMDN Code
T010299, T010201, T020699
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.

See all devices from ASAP International Sdn. Bhd. →

Properties

  • Contains Latex NoEUDAMEDYesEUDAMED

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