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Standard pyjamas

by Operating Theatre Medical (Zhijiang) Co., Ltd 12 variants

Ref 8880081, 8880062, 8880053, 8880082, 8880063, 8880060, 8880055, 8880050, 8880064, 8880080Model Blue/green/yellow/white/wine/purple tunic and pants

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6976128072000AE Basic UDI-DI Date19 Apr 2024RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Clean air suit
Model / Reference
Blue/green/yellow/white/wine/purple tunic and pants, 8880081, 8880062, 8880053, 8880082, 8880063, 8880060, 8880055, 8880050, 8880064, 8880080
Primary DI / UDI-DI
06976128079638, 06976128079577, 06976128079515, 06976128079645, 06976128079584, 06976128079553, 06976128079539, 06976128079485, 06976128079591, 06976128079621
Basic UDI-DI
6976128072000AE
Direct Marketing DI
06976128079638
06976128079577
06976128079515
06976128079645
06976128079584
06976128079553
06976128079539
06976128079485
06976128079591
06976128079621
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Belgium
Spain

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

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