Skip to content

CliniSafe (CliniSafe Guanti Antimicrobici in Nitrile Senza Polvere)

by Hartalega NGC Sdn. Bhd.

Ref AMG01315XL, AMG01315S, AMG01315M, AMG01315L, AMG01315XSModel 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100777HNGCTFMD012XB Basic UDI-DI Date10 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  • Withdrawn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), AMG01315XL, AMG01315S, AMG01315M, AMG01315L, AMG01315XS
Primary DI / UDI-DI
19551017623037, 19551017623006, 19551017623013, 19551017623020, 19551017622993
Basic UDI-DI
955100777HNGCTFMD012XB
Unit of Use DI
09551017623030, 09551017623009, 09551017623016, 09551017623023, 09551017622996
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.

See all devices from Hartalega Ngc Sdn. Bhd. →

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