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Orthora 200

by Mikrona Group AG

Ref 320.6500.01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP13534ORTHORA20027 Basic UDI-DI 112065100122UDI-DIDate17 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
320.6500.01
Primary DI / UDI-DI
112065100122
Basic UDI-DI
PP13534ORTHORA20027
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
Medical Purpose
The ORTHORA 200 Procedure Pack, featuring the integrated ORTHORA medical device, is intended for use in orthodontic treatment. It is designed to support the reception, positioning, and care of patients, as well as to assist with diagnostic, therapeutic, and preventive procedures within the scope of dental care.

Manufacturer details

EUDAMED SRN
CH-PR-000040363

Other devices from Mikrona Group AG

Properties

Other properties (1)

  • Sterile: No