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Pregnolia Control Unit - Console

by Pregnolia AG Switzerland EUDAMED

Ref 100044Model 100058

EMDN V030205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7649998703PregCUSY Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Pregnolia Control Unit
Model / Reference
100058, 100044
Primary DI / UDI-DI
07649998703079, 07649998703123
Basic UDI-DI
7649998703PregCUSY
EMDN Code
V030205 Obstetrics and gynecology measurement devices not included in other classes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000033377
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Pregnolia AG

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED f296e868-02bf-4e73-b3a2-297412eee5de 61 fields · synced 22 Oct 2026
  • EUDAMED 07649998703123|7649998703PREGCUSY 61 fields · synced 19 May 2026