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Sonio Suspect

by Sonio

Ref v1510(k) K243614

Sonio Suspect (v1) is a device classified as Class IIa in the EU and Class II in the US made by Sonio, registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 3770024341SuspectS6), cleared under FDA 510(k) K243614 on 21 Feb 2025 and listed in FDA GUDID since 3 Sep 2025 (UDI-DI 03770024341034), active as of 22 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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243614↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770024341SuspectS6 Basic UDI-DI 03770024341034UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03770024341034 UDI-DI Date3 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243614 Date21 Feb 2025ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3770024341SuspectS6 registered 24 Oct 2025 Active
  • FDA 510(k) K243614 decided 21 Feb 2025 Active
  • FDA GUDID UDI-DI 03770024341034 listed 3 Sep 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243614
  2. Listed FDA GUDID 03770024341034
  3. Registered EUDAMED 3770024341SuspectS6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Obstetrical/gynaecological ultrasound imaging system
Model / reference
v1 EUDAMED
1 GUDID
Primary DI / UDI-DI
03770024341034
Basic UDI-DI
3770024341SuspectS6
510(k) Number
FDA product code
POK
EMDN code
Z12080192 Prenatal diagnostic instruments - medical device software
GMDN term
Obstetrical/gynaecological ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2060
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
v1
GUDID
1
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.

Manufacturer details

EUDAMED SRN
FR-MF-000018467

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Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)