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Profeel Dhd Synthetic

by WRP Asia Pacific Sdn. Bhd. EUDAMED

Active European Union

Ref P3285-24

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9557795NEO-SG01EU Basic UDI-DIDate22 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Polychloroprene Surgical Gloves, Powder Free, Sterile
Model / Reference
P3285-24
Primary DI / UDI-DI
09557795006935
Basic UDI-DI
9557795NEO-SG01EU
EMDN Code
T01010201 Polychloropren surgical gloves
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
MY-MF-000004690
Authorised representative
REMESCO HANDELSGESMBH AT-AR-000002669

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Properties

  • Sterile

Other properties (12)

  • 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