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Sterile Standard Surgical Gowns

by Kenpax International Limited 38 variants

Ref 65-7135-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.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number48952371001UR Basic UDI-DI 04895237110068UDI-DIDate8 Mar 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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., 65-7135-S
Primary DI / UDI-DI
04895237110068
Basic UDI-DI
48952371001UR
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU 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