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Wibu+

by Maxter Glove Manufacturing Sdn Bhd Malaysia EUDAMED

Ref XL

EMDN T010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955500211637CR Basic UDI-DIDate27 Dec 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Powder Free Latex Examination Gloves
Model / Reference
XL
Primary DI / UDI-DI
09555002128784
Basic UDI-DI
955500211637CR
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000016719
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Maxter Glove Manufacturing Sdn Bhd

See all devices from Maxter Glove Manufacturing 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 09555002128784|955500211637CR 61 fields · synced 24 Oct 2026