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Iberian Care

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref EA201, EB201, EA101, EB2011

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955760100560GG Basic UDI-DIDate29 Mar 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  • Withdrawn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

Device Name
Latex Examination Polymer Powder Free Gloves
Nitrile Examination Powder Free Gloves
Latex Examination Powder Free Glove
Latex Examination Powdered Glove
Biodegradable Nitrile Examination Powder Free Gloves
Model / Reference
EA201, EB201, EA101, EB2011
Primary DI / UDI-DI
09551004309022, 09551004332433, 09551004308957, 09551004309039, 09551004309046, 09551004308940, 09551004309121, 09551004319229, 09551004364144, 09551004319250, 09551004345921, 09551004345945, 09551004332426, 09551004319267, 09551004319243, 09551004309138, 09551004308926, 09551004309169, 09551004319236, 09551004345969, 09551004345938, 09551004332440, 09551004345952, 09551004308933, 09551004309060
Basic UDI-DI
955760100560GG, 955760101940H5, 955760101080G4, 955760100000F5, 955760105220GQ
Direct Marketing DI
09551004309022
09551004332433
09551004309039
09551004309046
09551004309121
09551004319229
09551004319250
09551004332426
09551004319267
09551004319243
09551004309138
09551004309169
09551004319236
09551004332440
09551004309060
EMDN Code
T010201, T01020204
Device Class
Class I
Market of Registration
Spain

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

  • Contains Latex YesEUDAMEDNoEUDAMED
  • Reprocessed NoEUDAMEDYesEUDAMED

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: 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