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Emdamed Biotouch

by Hartalega NGC Sdn. Bhd. EUDAMED

Active European Union

Ref 400.121Model Biodegradable Nitrile Powder Free Examination Gloves

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100777HNGCTFMD004XC Basic UDI-DIDate21 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Biodegradable Nitrile Examination Gloves
Model / Reference
Biodegradable Nitrile Powder Free Examination Gloves, 400.121
Primary DI / UDI-DI
09551007775978
Basic UDI-DI
955100777HNGCTFMD004XC
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Netherlands

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