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MedicAmi

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref MED-100430146, MED-100430145, MED-100430142, MED-100430144, MED-100430143

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955760101940H5 Basic UDI-DIDate17 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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

Specification

EUDAMED

Device Name
Nitrile Examination Powder Free Gloves
Model / Reference
MED-100430146, MED-100430145, MED-100430142, MED-100430144, MED-100430143
Primary DI / UDI-DI
09551004301460, 09551004301453, 09551004331528, 09551004331542, 09551004301439, 09551004331559, 09551004301422, 09551004331535, 09551004301446, 09551004331566
Basic UDI-DI
955760101940H5
Direct Marketing DI
09551004301460
09551004301453
09551004331528
09551004331542
09551004301439
09551004331559
09551004301422
09551004331535
09551004301446
09551004331566
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
MY-MF-000009690
Authorised representative
Ulma International GmbH DE-AR-000010015

Other devices from Top Glove Sdn. Bhd.

See all devices from Top Glove 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