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Callus

by DenTi System Kft. Hungary EUDAMED

Ref 8000-004 EMDN Q010399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number599957543000000000026DQ Basic UDI-DIDate3 Feb 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Dental Implant Hand Adapter
Model / Reference
8000-004
Primary DI / UDI-DI
05999575434233
Basic UDI-DI
599957543000000000026DQ
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class I
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000006488

Other devices from DenTi System Kft.

See all devices from DenTi System Kft. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 b18728de-e3f0-4a53-b615-1e2db4664cb8 61 fields · synced 25 Oct 2026