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Skytec

by Globus (Shetland) Ltd United Kingdom EUDAMED

Ref SKG00630BHModel TX630

EMDN T01020204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060855886SKY630EU Basic UDI-DIDate29 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Skytec TX630 Black Nitrile Disposable Gloves
Model / Reference
TX630, SKG00630BH
Primary DI / UDI-DI
05060855886964
Basic UDI-DI
5060855886SKY630EU
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000007384
Authorised representative
Globus EMEA Ltd IE-AR-000002785

Other devices from Globus (Shetland) Ltd

See all devices from Globus (Shetland) Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 76e3175d-fb92-4db0-9a66-3e64ac1be79e 61 fields · synced 22 Oct 2026