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CliniSafe (CliniSafe Guanti Antimicrobici in Nitrile Extended Cuff)

by Hartalega NGC Sdn. Bhd. 5 variants

Ref AMG01316LModel Antimicrobial Nitrile Powder Free Examination Gloves (AMG)

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 Number955100777HNGCTFMD012XB Basic UDI-DI 19551017625376UDI-DIDate10 Jan 2025RegisteredStatusActive

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  • Withdrawn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
Antimicrobial Nitrile Examination Gloves (AMG)
Model / Reference
Antimicrobial Nitrile Powder Free Examination Gloves (AMG), AMG01316L
Primary DI / UDI-DI
19551017625376
Basic UDI-DI
955100777HNGCTFMD012XB
Unit of Use DI
09551017625379
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Italy

Manufacturer details

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

Other devices from Hartalega Ngc Sdn. Bhd.

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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