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myster_mini

by DENOVA Co., Ltd. EUDAMED

Active European Union

Ref DHA-2e

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2975-MED-2612701 Date7 May 2026IssuedStatusActive expires 6 May 2031

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  • Withdrawn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)
  • 2975-MED-2612701 Issued

    Quality management system EU MDR

    Notified body
    Notified body 2975
    Issued
    7 May 2026
    Expires
    6 May 2031

Specification

EUDAMED

Device Name
Moist Heat Sterilizer for Dental Handpieces
Model / Reference
DHA-2e
Primary DI / UDI-DI
08809954560057
Basic UDI-DI
880995456ms0015Z
EMDN Code
Z12011305 Small load autoclaves with a chamber smaller than 1 standard sterilisation unit
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
KR-MF-000051069
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

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