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Elite Balloon Cannula 5mm x 100mm

by Unimicro Medical Systems (Shenzhen) Co., Ltd FDA registration: China EUDAMED

Ref PS1515 EMDN K01010180

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05051223035466 Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Elite Balloon Cannula 5mm x 100mm
Model / Reference
PS1515
Primary DI / UDI-DI
05051223035466
Basic UDI-DI
B-05051223035466
EMDN Code
K01010180 Trocar, single-use - accessories
Device Class
Class IIa
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 05051223035466|B-05051223035466 61 fields · synced 24 Oct 2026