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Isogown

by RAYS S.p.A. Italy EUDAMED

Ref 401283V/L, 401283V/MModel Non Sterile Isolation Gown

EMDN T0205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805621138IsolationGownsYD Basic UDI-DIDate21 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non Sterile Isolation Gown
Model / Reference
Non Sterile Isolation Gown, 401283V/L, 401283V/M
Primary DI / UDI-DI
80327641532438, 80327641532360
Basic UDI-DI
805621138IsolationGownsYD
Direct Marketing DI
80327641532438
80327641532360
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
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 (2)

  • EUDAMED ee7f38bd-b8a3-41e8-8746-b7176b51e389 61 fields · synced 22 Oct 2026
  • EUDAMED 80327641532360|805621138ISOLATIONGOWNSYD 61 fields · synced 18 May 2026