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Disposable Isolation Gown

by Hubei Rongqing Medical Equipment Co., Ltd EUDAMED

Active European Union

Ref PP Isolation gownModel PP Isolation gown,SMS Isolation gown,SMMS Isolation gown,SMMMS Isolation gown,Nonwoven gown,PE Laminated gown,Patient Isolation gown,Scrub Suit,Patient Suit,CPE gown

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697863841ISOLATION018F Basic UDI-DIDate15 May 2025RegisteredStatusActive

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  • Withdrawn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
Disposable Isolation Gown
Model / Reference
PP Isolation gown, SMS Isolation gown, SMMS Isolation gown, SMMMS Isolation gown, Nonwoven gown, PE Laminated gown, Patient Isolation gown, Scrub Suit, Patient Suit, CPE gown
Primary DI / UDI-DI
06978638410505
Basic UDI-DI
697863841ISOLATION018F
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047357
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Rongqing Medical Equipment Co., Ltd

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