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Isolation Gown

by Xiantao Fushi Protective Products Co., Ltd EUDAMED

Active European Union

Ref MModel S, M, L, XL,2XL,3XL,4XL,5XL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697506346isogownQA Basic UDI-DIDate25 Feb 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  • Withdrawn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
Isolation Gown
Model / Reference
S, M, L, XL, 2XL, 3XL, 4XL, 5XL
Primary DI / UDI-DI
16975063460317
Basic UDI-DI
697506346isogownQA
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000017275
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao Fushi Protective Products Co., Ltd

See all devices from Xiantao Fushi Protective Products 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