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Disposable Isolation Gown

by Xiantao Softmed Protective Products Co., Ltd EUDAMED

Active European Union

Ref XXXXLModel 110x130 cm, 115x137cm, 120x140cm, 125x145cm, 130x160cm, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, XXXXXXL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697543051DIG01DB Basic UDI-DIDate7 Jul 2023RegisteredStatusActive

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  • Withdrawn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
110x130 cm, 115x137cm, 120x140cm, 125x145cm, 130x160cm, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, XXXXXXL
Primary DI / UDI-DI
06975430513113
Basic UDI-DI
697543051DIG01DB
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011460
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao Softmed Protective Products Co., Ltd

See all devices from Xiantao Softmed 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