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Skytec

by Globus (Shetland) Ltd EUDAMED

Active European Union

Ref SKYUTAH4, SKG00830DF, SKG00530EL, SKG00310DH, SKG00924BL, SKG00430DD, SKG04524EB, SKG00830DD, SKYTEAL4, SKGV00924BF, SKG00724BJ, SKG04525EJ, SKG00510DH, SKG00530EH, SKG00924BH, SKG04525EL, SKYTEAL3, SKYIRIS1, SKG00324IF, SKG00424DJ, SKG00510DL, SKG00830DH, SKG04525EF, SKG00925GL, SKG00424DH, SKG00510DF, SKG04525EB, SKG00924BJ, SKG00524BH, SKG00424DF, SKGV00924BJ, SKG00428DH, SKG00524BF, SKG04525EH, SKG00324ID, SKG04524ED, SKYIRIS4, SKYUTAH1, SKG00510DD, SKG00510DJ, SKG00630BD, SKG00424DL, SKG00725GJ, SKYUTAH2, SKGV00924BLModel UTAH, TX830, TX530, AX310, TX924, TX430, TX4524, TEAL, VENDING TX924, TX724, TX4525, TX510, TX324, TX424, TX925, TX524, TX428, IRIS, TX630, TX725

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060149204SKYUTAHM2 Basic UDI-DIDate29 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Skytec Utah Nitrile Disposable Gloves
Skytec TX830 Blue Nitrile Disposable Gloves
Skytec TX530 Green Nitrile Disposable Gloves
Skytec AX310 Blue Disposable Nitrile Gloves
Skytec TX924 Black Nitrile Disposable Gloves
Skytec TX430 Blue Nitrile Disposable Gloves
Skytec TX4524 Green Biodegradable Nitrile Disposable Gloves
Skytec Teal Nitrile Disposable Gloves
Skytec Vending TX924 Black Nitrile Disposable Gloves
Skytec TX724 Black Nitrile Disposable Gloves
Skytec TX4525 Green Nitrile Disposable Gloves
Skytec TX510 Blue Nitrile Disposable Gloves
Skytec TX324 Violet Biodegradable Nitrile Disposable Glove
Skytec TX424 Blue Nitrile Disposable Gloves
Skytec TX925 Orange Nitrile Disposable Gloves
Skytec TX524 Black Nitrile Disposable Gloves
Skytec NX428 Blue Nitrile Disposable Gloves
Skytec Iris Nitrile Disposable Gloves
Skytec TX630 Black Nitrile Disposable Gloves
Skytec TX725 Orange Nitrile Disposable Gloves
Model / Reference
UTAH, SKYUTAH4, TX830, SKG00830DF, TX530, SKG00530EL, AX310, SKG00310DH, TX924, SKG00924BL, TX430, SKG00430DD, TX4524, SKG04524EB, SKG00830DD, TEAL, SKYTEAL4, VENDING TX924, SKGV00924BF, TX724, SKG00724BJ, TX4525, SKG04525EJ, TX510, SKG00510DH, SKG00530EH, SKG00924BH, SKG04525EL, SKYTEAL3, SKYIRIS1, TX324, SKG00324IF, TX424, SKG00424DJ, SKG00510DL, SKG00830DH, SKG04525EF, TX925, SKG00925GL, SKG00424DH, SKG00510DF, SKG04525EB, SKG00924BJ, TX524, SKG00524BH, SKG00424DF, SKGV00924BJ, TX428, SKG00428DH, SKG00524BF, SKG04525EH, SKG00324ID, SKG04524ED, IRIS, SKYIRIS4, SKYUTAH1, SKG00510DD, SKG00510DJ, TX630, SKG00630BD, SKG00424DL, TX725, SKG00725GJ, SKYUTAH2, SKGV00924BL
Primary DI / UDI-DI
05060149200414, 05060855886186, 05060855886629, 05056739402511, 05060988800950, 05060988807225, 05060855888456, 05060855886179, 05060149205969, 05060988806907, 05060855887749, 05060855888388, 05056739400791, 05060855886582, 05060988800912, 05060855888395, 05060149205952, 05060149205945, 05060855888630, 05060855886360, 05056739400838, 05060855886193, 05060855888364, 05060988801025, 05060855886346, 05056739400777, 05060855888340, 05060988800936, 05060855887848, 05060855886322, 05060988806945, 05060855886469, 05060855887831, 05060855888371, 05060855888623, 05060855888463, 05060149204900, 05060431751211, 05056739400753, 05056739400814, 05060855886940, 05060855886384, 05060855887640, 05060149200391, 05060988806969, 05060149204870
Basic UDI-DI
5060149204SKYUTAHM2, 5060855886SKY830F6, 5060855886SKY530EP, 5056739402SKY310BB, 5060988802SKY924FD, 5060988807SKY430H4, 5060855888SKY4524SN, 5060149205SKYTEALKB, 5060988806SKY924VW9, 5060855887SKY724FP, 5060855888SKY4525SQ, 5056739400SKY510AK, 5060855888SKY324FL, 5060855886SKY424EP, 5060988802SKY925FF, 5060855887SKY524FD, 5060855886SKY428EX, 5060149204SKYIRISKJ, 5060855886SKY630EU, 5060855887SKY725FR
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

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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