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

Active European Union

Ref 27-38-M

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000445DN25314T Basic UDI-DIDate18 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR24/00000049 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    24 Jun 2024
    Expires
    24 Jun 2029

Specification

EUDAMED

Device Name
Sterile single use dental needles
Model / Reference
27-38-M
Primary DI / UDI-DI
08800044502759
Market of Registration
Italy

Manufacturer details

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

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