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Rosetta SM HO1/Z9512

by Hass Corp. South Korea EUDAMED

Ref SM HO1/Z9512Model Rosetta

EMDN Q010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800391546598 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Rosetta, SM HO1/Z9512
Primary DI / UDI-DI
08800391546598
Basic UDI-DI
B-08800391546598
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011621
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Hass Corp.

See all devices from Hass Corp. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 08800391546598|B-08800391546598 61 fields · synced 24 Oct 2026