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Maxter

by Maxter Glove Manufacturing Sdn Bhd 49 variants

Ref S, Medium, XS, Small, Large, L, X-Small, XL, X-Large, XXL, M

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 Number955500211638CT Basic UDI-DI Date8 Dec 2021RegisteredStatusActive

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  • Withdrawn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 Nitrile Examination Gloves
Powdered Latex Examination Gloves
Powder Free Latex Examination Gloves
Model / Reference
S, Medium, XS, Small, Large, L, X-Small, XL, X-Large, XXL, M
Primary DI / UDI-DI
09555002107116, 09555002105730, 08594065950223, 09555002104054, 09555002105778, 09555002105747, 09555002125103, 09555002105792, 09555002112288, 09555002122652, 09555002105815, 09555002105846, 09555002105761, 09555002115005, 09555002105754, 09555002117962, 09555002105723, 09555002125202, 09555002114800, 09555002122676, 09555002128265, 09555002104061, 09555002114794, 09555002107147, 09555002111427, 09555002125226, 09555002112714, 08594065950742, 09555002128272, 08594065950728, 09555002105822, 09555002112264, 09555002112721, 09555002107123, 09555002111465, 09555002104085, 09555002114404, 09555002111410, 09555002114428, 09555002125219, 09555002112776, 09555002112806, 09555002114787
Basic UDI-DI
955500211638CT, 955500211636CP, 955500211637CR
EMDN Code
T01020204, T010201
Device Class
Class I
EU market of registration
Hungary
Greece
Czechia
Slovenia
Lithuania
Croatia
Netherlands
Poland

Manufacturer details

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

Other devices from Maxter Glove Manufacturing Sdn Bhd

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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