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Osstem

by C-K Dental Ind.co., Ltd. 12 variants

Ref 27-30-I

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000445DN25314T Basic UDI-DI 08800044510990UDI-DIDate18 May 2025RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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 dental needles
Model / Reference
27-30-I
Primary DI / UDI-DI
08800044510990
Basic UDI-DI
88000445DN25314T
EMDN Code
A010601 Carpule needles
Device Class
Class IIa

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
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No