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Axglove

by Axg Industries Sdn Bhd 2 variants

Ref PB (G2)Model POWDER FREE LATEX EXAMINATION GLOVE

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955571000OCFTLFC Basic UDI-DI 95557100001980UDI-DIDate15 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Powder Free Latex Examination Glove
Model / Reference
POWDER FREE LATEX EXAMINATION GLOVE, PB (G2)
Primary DI / UDI-DI
95557100001980
Basic UDI-DI
955571000OCFTLFC
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
MY-MF-000018723
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Axg Industries Sdn Bhd

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