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Hogen Spitze Endo

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

Ref ED23-25-SModel Half Cut, Single Side Vent, Double Side Vent, Blunt End Open

Active European Union

CE MDR

Valid until

24 Jun 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000445ED1631ZM Basic UDI-DI 08800044503664UDI-DIDate20 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR24/00000049 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    24 Jun 2024
    Expires
    24 Jun 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile single use endodontic irrigation needles
Model / Reference
Half Cut, Single Side Vent, Double Side Vent, Blunt End Open, ED23-25-S
Primary DI / UDI-DI
08800044503664
Basic UDI-DI
88000445ED1631ZM
EMDN Code
A010602 Dental irrigation needles
Device Class
Class IIa
EU market of registration
Bulgaria

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

  • Sterile

Other properties (12)

  • 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