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Sontara Surgical Gown Standard "L"

by Cross Protection (M) Sdn Bhd EUDAMED

Active European Union

Ref ST003Model THEATRE GOWN

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955571350APPARELU7 Basic UDI-DIDate2 Apr 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  • Withdrawn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
Cross Protection Theatre Gown
Model / Reference
THEATRE GOWN, ST003
Primary DI / UDI-DI
09555713503306
Basic UDI-DI
955571350APPARELU7
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
MY-MF-000029344
Authorised representative
Advena Limited MT-AR-000000234

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Properties

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