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by Hartalega NGC Sdn. Bhd. 3 variants

Ref 90122Model Nitrile Powder Free Examination Gloves

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100777HNGCTFMD005AQ8 Basic UDI-DI 09551007779129UDI-DIDate22 Oct 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  • Withdrawn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
Nitrile Examination Gloves
Model / Reference
Nitrile Powder Free Examination Gloves, 90122
Primary DI / UDI-DI
09551007779129
Basic UDI-DI
955100777HNGCTFMD005AQ8
Unit of Use DI
09551007779181
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
MY-MF-000010459
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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