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Elite Optical Balloon Trocar 12mm x 100mm with Additional Cannula

by Unimicro Medical Systems (Shenzhen) Co., Ltd

Ref PS1322

Active European Union

CE MDD

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/MDD NumberB-05051223035428 Basic UDI-DI 05051223035428UDI-DIDate17 Jun 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Elite Optical Balloon Trocar 12mm x 100mm with Additional Cannula
Model / Reference
PS1322
Primary DI / UDI-DI
05051223035428
Basic UDI-DI
B-05051223035428
EMDN Code
K01010103 Optical trocar, single-use
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000014590
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Unimicro Medical Systems (Shenzhen) Co., Ltd.

See all devices from Unimicro Medical Systems (Shenzhen) Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No