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C-K Irrigation Needle Tips

by C-K Dental Ind.co., Ltd. South Korea EUDAMED

Ref IR16-13-BT EMDN A010602

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000445IR163186 Basic UDI-DIDate18 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Irrigation needle tips
Model / Reference
IR16-13-BT
Primary DI / UDI-DI
08800044501424
Basic UDI-DI
88000445IR163186
EMDN Code
A010602 Dental irrigation needles
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
KR-MF-000022929
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from C-K Dental Ind.co., Ltd.

See all devices from C-K Dental Ind.co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED b3147cdf-d5c5-4d47-a23a-d396a1977da7 61 fields · synced 22 Oct 2026