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Tony-App

by Sanero Medical GmbH

Ref Tony-App

Active European Union

CE MDR

Valid until

7 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Berlin Cert GmbH

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 Number426239551TONY01HR Basic UDI-DI 04262395511004UDI-DIDate10 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-24-024-S-IX Active

    Quality management system EU MDR

    Certifier
    Berlin Cert GmbH 0633
    Issued
    21 Jul 2025
    Expires
    7 Jan 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tony-App
Model / Reference
Tony-App
Primary DI / UDI-DI
04262395511004
Basic UDI-DI
426239551TONY01HR
Direct Marketing DI
04262395511004
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000027960

Other devices from Sanero Medical GmbH

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