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Maia 1.0

by Tiplu GmbH Germany EUDAMED

Ref 1.0

EMDN V92

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-23-152-S-IX Date8 Jan 2025IssuedStatusExpiring expires 7 Jan 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-23-152-S-IX Issued Expires in 74 days

    Quality management system EU MDR

    Notified body
    Notified body 0633
    Issued
    8 Jan 2025
    Expires
    7 Jan 2027

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Maia
Model / Reference
1.0
Primary DI / UDI-DI
04262436480016
Basic UDI-DI
426243648426243648000984
Direct Marketing DI
04262436480016
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000036643

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 410c9598-f986-4e08-bcca-27192486e23b 61 fields · synced 22 Oct 2026