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2.0MHz

by Edan Instruments, Inc.

Part of a family of 23 devices: see the family page

Ref SONOTRAX-2MHz

2.0MHz is a device classified as Class IIa in the EU and Class II in the US made by Edan Instruments, Inc., registered in EUDAMED on 10 Oct 2026 (Basic UDI-DI 6944138UTOBC9), cleared under FDA 510(k) K150901 on 1 Jul 2015 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06944413805538), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K150901; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150901

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6944138UTOBC9 Basic UDI-DI 06944413805538UDI-DIDate10 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413805538 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150901 Date1 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6944138UTOBC9 registered 10 Oct 2026 Active
  • FDA 510(k) K150901 decided 1 Jul 2015 Active
  • FDA GUDID UDI-DI 06944413805538 listed 1 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1141-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K150901

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150901
  2. Listed FDA GUDID 06944413805538
  3. Recall initiated FDA recalls Z-1141-2026
  4. Registered EUDAMED 6944138UTOBC9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ultrasonic Transducer
Generic name
Foetal Doppler system probe
Model / reference
SONOTRAX-2MHz EUDAMED
2.0MHz GUDID
Primary DI / UDI-DI
06944413805538
Basic UDI-DI
6944138UTOBC9
510(k) Number
FDA product code
HEP
EMDN code
Z11040299 Ultrasound probes – other
GMDN term
Foetal Doppler system probe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.2660
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SONOTRAX-2MHz
GUDID
2.0MHz
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Foetal Doppler system probe

Cleared under the same submission (K150901)

and 8 more cleared under K150901

Similar devices in this category

Other devices filed under ULTRASOUND PROBES – OTHER.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)