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Sonio Detect

by Sonio 2 variants

Ref v2

Sonio Detect (v2) is a device classified as Class IIa in the EU and Class II in the US made by Sonio, registered in EUDAMED on 29 Jul 2024 (Basic UDI-DI 3770024341DetectMM), cleared under FDA 510(k) K240406 on 26 Apr 2024 and listed in FDA GUDID since 13 Jan 2025 (UDI-DI 03770024341041), 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) K240406

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03770024341041 UDI-DI Date13 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3770024341DetectMM Basic UDI-DI 03770024341041UDI-DIDate29 Jul 2024RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK240406 Date26 Apr 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3770024341DetectMM registered 29 Jul 2024 Active
  • FDA 510(k) K240406 decided 26 Apr 2024 Active
  • FDA GUDID UDI-DI 03770024341041 listed 13 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240406
  2. Registered EUDAMED 3770024341DetectMM
  3. Listed FDA GUDID 03770024341041

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  • Withdrawn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

Generic name
Ultrasound imaging system application software
Model / reference
v2 EUDAMED
2 GUDID
Primary DI / UDI-DI
03770024341041
Basic UDI-DI
3770024341DetectMM
Direct marketing DI
03770024341041
510(k) Number
FDA product code
IYN, IYO, QIH
EMDN code
Z12080192 Prenatal diagnostic instruments - medical device software
GMDN term
Ultrasound imaging system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1560, 892.2050
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
v2
GUDID
2
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

Similar devices in this category

Other devices filed under PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Sonio

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Properties

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