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Isolation Gown

by Sword Xiantao Disposable Protective Products Factory EUDAMED

Active European Union

Ref ML36326Model 110, 110A, 115, 115A, 115B, 116, 120, 125, 130, 130A, 136, 139, 140, 140A, 150, XS, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, Scrub suits, Scrub shirt and pant, Conjoined Type, Split Type, customizable

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697163167IGZL Basic UDI-DIDate21 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  • Withdrawn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
Isolation Gown
Model / Reference
110, 110A, 115, 115A, 115B, 116, 120, 125, 130, 130A, 136, 139, 140, 140A, 150, XS, S, M, L, XL, XXL, XXXL, XXXXL, XXXXXL, Scrub suits, Scrub shirt and pant, Conjoined Type, Split Type, customizable, ML36326
Primary DI / UDI-DI
06971631674530
Basic UDI-DI
697163167IGZL
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000009766
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Sword Xiantao Disposable Protective Products Factory

See all devices from Sword Xiantao Disposable Protective Products Factory →

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