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Add-on device: SOMNOtouch NIBP (pediatric)

by SOMNOmedics AG Germany EUDAMED

Ref TON105AModel SOMNOtouch NIBP EMDN Z12100501

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504134SOMNOtouchNIBPXX Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
SOMNOtouch NIBP, TON105A
Primary DI / UDI-DI
04250413407170
Basic UDI-DI
42504134SOMNOtouchNIBPXX
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Medical Purpose
The SOMNOtouch™ NIBP is a portable device for recording physiological signals. The SOMNOtouch™ NIBP is used as a long-term blood pressure and long-term ECG device.

Manufacturer details

EUDAMED SRN
DE-PR-000042026

Other devices from SOMNOmedics AG

See all devices from SOMNOmedics AG →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 04250413407170|42504134SOMNOTOUCHNIBPXX 61 fields · synced 25 Oct 2026