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Isolation Gown S

by Hygitech EUDAMED

Active European Union

Ref HY1-50041Model Isolation and Surgical gowns

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0425-MDR-030222-00 Date30 Sep 2026IssuedStatusActive expires 11 Apr 2028

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030222-00 Active

    Quality assurance EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    30 Sep 2026
    Expires
    11 Apr 2028

Specification

EUDAMED

Device Name
Isolation and Surgical gowns
Model / Reference
Isolation and Surgical gowns, HY1-50041
Primary DI / UDI-DI
03615140006514
Basic UDI-DI
361514H2PRIN112WJ
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000007549

Other devices from Hygitech

See all devices from Hygitech →

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