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Mediok Optima Cornflower

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref TDE-100433205, TDE-100433203, TDE-100433206, TDE-100431585, TDE-100431586, TDE-100431584, TDE-100431583, TDE-100433204

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  • Withdrawn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

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
Mediok Optima Cornflower
Mediok Optima
Device Name
Nitrile Examination Powder Free Gloves
Model / Reference
TDE-100433205, TDE-100433203, TDE-100433206, TDE-100431585, TDE-100431586, TDE-100431584, TDE-100431583, TDE-100433204
Primary DI / UDI-DI
09551004332051, 09551004332037, 09551004332068, 09551004315856, 09551004315863, 09551004315849, 09551004315832, 09551004332044
Basic UDI-DI
955760101940H5
Direct Marketing DI
09551004332051
09551004332037
09551004332068
09551004315856
09551004315863
09551004315849
09551004315832
09551004332044
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Germany

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