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Patient Kit

by Operating Theatre Medical (Zhijiang) Co., Ltd 4 variants

Ref KPC-SMS-4XLModel Blue/green/white/yellow patient kit

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 Number6976128076800CJ Basic UDI-DI 06976128076859UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Blue/green/white/yellow patient kit, KPC-SMS-4XL
Primary DI / UDI-DI
06976128076859
Basic UDI-DI
6976128076800CJ
Direct Marketing DI
06976128076859
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

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