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Prosenso

by Top Glove Sdn. Bhd. EUDAMED

Active European Union

Ref EWBIO35M-M, EWWHI35M-S, EWLTX58M-XL, EWBIO35M-L, EWBIO35M-XS, EWLTX58M-L, EWBIO35M-XL, EW2020-XL, EWWHI35M-L, EWBLK35M-S, EW2020-L, EWBIO35M-S, EWLTX58M-S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955760105220GQ Basic UDI-DIDate12 Aug 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  • Withdrawn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
Biodegradable Nitrile Examination Powder Free Gloves
Nitrile Examination Powder Free Gloves
Latex Examination Polymer Powder Free Gloves
Model / Reference
EWBIO35M-M, EWWHI35M-S, EWLTX58M-XL, EWBIO35M-L, EWBIO35M-XS, EWLTX58M-L, EWBIO35M-XL, EW2020-XL, EWWHI35M-L, EWBLK35M-S, EW2020-L, EWBIO35M-S, EWLTX58M-S
Primary DI / UDI-DI
09551004341848, 09551004341633, 09551004341961, 09551004341855, 09551004341824, 09551004341954, 09551004341862, 09551004312268, 09551004341657, 09551004341732, 09551004312251, 09551004341831, 09551004341930
Basic UDI-DI
955760105220GQ, 955760101940H5, 955760100560GG
Direct Marketing DI
09551004341848
09551004341633
09551004341961
09551004341855
09551004341824
09551004341954
09551004341862
09551004341657
09551004341732
09551004341831
09551004341930
EMDN Code
T01020204, T010201
Device Class
Class I
Market of Registration
Denmark

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 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