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Visit Gown

by Operating Theatre Medical co. Ltd.

Ref I001202OTMModel Blue/green/yellow/white visit gown with elastic cuff or knitted cuff

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697330123400044 Basic UDI-DI 06973301234013UDI-DIDate17 Jul 2023RegisteredStatusWithdrawn

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Disposable visit gown
Model / Reference
Blue/green/yellow/white visit gown with elastic cuff or knitted cuff, I001202OTM
Primary DI / UDI-DI
06973301234013
Basic UDI-DI
697330123400044
Unit of Use DI
16973301234010
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000001419
Authorised representative
mono-uso nv BE-AR-000001322

Other devices from Operating Theatre Medical (Zhijiang) Co., Ltd

See all devices from Operating Theatre Medical (Zhijiang) 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