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Sterile Standard Surgical Gowns

by Kenpax International Limited EUDAMED

Active European Union

Ref 67-5148-SModel Standard Gown; Standard Plus Gown; Performance Plus Gown; Premium Performance Plus Gown; EN Standard S.Gown+1 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR L-XXL Long; etc.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number48952371001UR Basic UDI-DIDate8 Mar 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  • Withdrawn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

Model / Reference
Standard Gown, Standard Plus Gown, Performance Plus Gown, Premium Performance Plus Gown, EN Standard S.Gown+1 Towels+CSR M-XXL, EN Standard Surgical Gown+2 Towels+CSR M-XXL, EN Standard Surgical Gown+2 Towels+CSR L-XXL Long, etc., 67-5148-S
Primary DI / UDI-DI
04895237110563
Basic UDI-DI
48952371001UR
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
HK-MF-000021152
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Kenpax International Limited

See all devices from Kenpax International Limited →

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