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Irrigation Needle Tips

by C-K Dental Ind.co., Ltd. 24 variants

Ref IR25-15-BT-BUModel Bent, Straight, Straight Cap

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000445IR163186 Basic UDI-DI Date18 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  • Withdrawn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

Trade Name
Irrigation Needle Tips
C-K Irrigation Needle Tips
Model / Reference
Bent, Straight, Straight Cap, IR25-15-BT-BU
Primary DI / UDI-DI
08800044513441, 08800044512604
Basic UDI-DI
88000445IR163186
EMDN Code
A010602 Dental irrigation needles
Device Class
Class I
EU market of registration
Italy

Manufacturer details

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

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

  • Trend Ject

    Class IIa

  • Hogen Spitze Irrigation Needle Tips

    Class I

  • C-K Endo

    Class IIa

  • inline

    Class IIa

  • Dr. Protect

    Class IIa

  • Trend

    Class IIa

See all devices from C-K Dental Ind.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