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Gensuapp

by MiyaHealth Pte. Ltd. Singapore EUDAMED

Ref GENSUAPP01 EMDN V92

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G489GENSUAPP0184 Basic UDI-DIDate16 Nov 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Gensuapp
Model / Reference
GENSUAPP01
Primary DI / UDI-DI
+G489GENSUAPP010
Basic UDI-DI
++G489GENSUAPP0184
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
SG-MF-000038692
Authorised representative
Access-2-Healthcare UG DE-AR-000020421

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 c55aa707-1515-47b7-8a35-03ca264836d0 61 fields · synced 23 Oct 2026