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Biosoft Pf Type 35

by RAYS S.p.A. Italy EUDAMED

Ref DAR NI XLModel Non Sterile Examination Glove EMDN T01020204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805621138Gloves4T Basic UDI-DIDate29 Jan 2025RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Non Sterile Examination Glove
Model / Reference
Non Sterile Examination Glove, DAR NI XL
Primary DI / UDI-DI
80327641518364
Basic UDI-DI
805621138Gloves4T
Direct Marketing DI
80327641518364
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009229

Other devices from RAYS S.p.A.

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED b97c0f8e-4a54-42ea-b9f0-a64ecb3f8ff4 61 fields · synced 24 Oct 2026