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Svizera Europe

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref SVI-100430536, SVI-100430513, SVI-100430533, SVI-100430524, SVI-100430545, SVI-100430546, SVI-100430542, SVI-100430503, SVI-100430514, SVI-100430504, SVI-100430505, SVI-100430525, SVI-100430522, SVI-100430506, SVI-100430532

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  • Withdrawn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
Latex Examination Polymer Powder Free Gloves
Nitrile Examination Polymer Powder Free Glove
Latex Examination Powdered Glove
Model / Reference
SVI-100430536, SVI-100430513, SVI-100430533, SVI-100430524, SVI-100430545, SVI-100430546, SVI-100430542, SVI-100430503, SVI-100430514, SVI-100430504, SVI-100430505, SVI-100430525, SVI-100430522, SVI-100430506, SVI-100430532
Primary DI / UDI-DI
09551004305369, 09551004305130, 09551004305338, 09551004305246, 09551004305451, 09551004305468, 09551004305420, 09551004305031, 09551004305147, 09551004305048, 09551004305055, 09551004305253, 09551004305222, 09551004305062, 09551004305321
Basic UDI-DI
955760101940H5, 955760100560GG, 955760103340GM, 955760100000F5
EMDN Code
T01020204, T010201
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.

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Properties

  • Contains Latex NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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