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Patient Gown

by Feixi Hongwei Medical Devices Co., Ltd China EUDAMED

Ref FMCHEMISEOPModel PP Isolation gown; SMS Isolation gown; SMMS Isolation gown; SMMMS Isolation gown; Nonwoven Gown; PE Laminated Isolation gown; Patient gown; Visitor Gown; Scrub Suit; Patient Suit; CPE Gown EMDN T0205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697491661ISOG0112T Basic UDI-DIDate6 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Disposable Isolation Gown
Model / Reference
PP Isolation gown, SMS Isolation gown, SMMS Isolation gown, SMMMS Isolation gown, Nonwoven Gown, PE Laminated Isolation gown, Patient gown, Visitor Gown, Scrub Suit, Patient Suit, CPE Gown, FMCHEMISEOP
Primary DI / UDI-DI
06974916610063
Basic UDI-DI
697491661ISOG0112T
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000033411
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Feixi Hongwei Medical Devices Co., Ltd

See all devices from Feixi Hongwei Medical Devices Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED c73b30b5-3978-4fea-b920-9cc2bf5ff098 61 fields · synced 22 Oct 2026