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Somfit Pro System

by Compumedics Limited 2 variants

Ref 9037-0020-00Model Somfit Respifit Module – Somfit Pro Upgrade Kit, Somfit

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09342451006592 Basic UDI-DI 09342451006592UDI-DIDate17 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Trade Name
Respifit Device - Somfit Pro upgrade kit
Device Name
Somfit Pro System
Somfit System
Model / Reference
Somfit Respifit Module – Somfit Pro Upgrade Kit, 9037-0020-00, Somfit
Primary DI / UDI-DI
09342451006592
Basic UDI-DI
B-09342451006592, 9342451SomfitTU
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000050437
Authorised representative
Compumedics EUROPE GmbH DE-AR-000039096

Other devices from Compumedics Limited

See all devices from Compumedics Limited →

Properties

  • 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