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Biosoft Pf Type 65

by RAYS S.p.A. Italy EUDAMED

Ref DAR NI CHE MModel 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
  • 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 CHE M
Primary DI / UDI-DI
80340559101602
Basic UDI-DI
805621138Gloves4T
Direct Marketing DI
80340559101602
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.

See all devices from RAYS S.p.A. →

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 43d39a00-4d36-4357-b441-70ea6cbf3f74 61 fields · synced 24 Oct 2026