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Sterile clean air suit

by Operating Theatre Medical (Zhijiang) Co., Ltd 3 variants

Ref I001203OTM, I001204OTM, I001201OTM, I001207OTM, I001205OTMModel Blue/green/yellow/white/wine/purple tunic and pants with EO sterilization

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6976128078500CH Basic UDI-DI Date19 Apr 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Blue/green/yellow/white/wine/purple tunic and pants with EO sterilization, I001203OTM, I001204OTM, I001201OTM, I001207OTM, I001205OTM
Primary DI / UDI-DI
06976128078525, 06976128078532, 06976128078501, 06976128078563, 06976128078549
Basic UDI-DI
6976128078500CH
Direct Marketing DI
06976128078525
06976128078532
06976128078501
06976128078563
06976128078549
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000038254
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

  • Sterile

Other properties (12)

  • 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