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Sonio Detect

by Sonio 2 variants

Ref v1

Sonio Detect (v1) 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 (1 earlier submission) and listed in FDA GUDID since 16 Feb 2024 (UDI-DI 03770024341027), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240406↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770024341DetectMM Basic UDI-DI 03770024341027UDI-DIDate29 Jul 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK240406 Date26 Apr 2024IssuedStatusActive
United StatesGUDID listing GUDID Number03770024341027 UDI-DI Date16 Feb 2024ListedStatusListed GUDID: not in commercial distribution

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· +1 more in the status table
  • FDA GUDID UDI-DI 03770024341027 listed 16 Feb 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K230365
  2. Listed FDA GUDID 03770024341027
  3. Cleared FDA 510(k) K240406
  4. Registered EUDAMED 3770024341DetectMM

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  • Withdrawn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
Ultrasound imaging system application software
Model / reference
v1 EUDAMED
1 GUDID
Primary DI / UDI-DI
03770024341027
Basic UDI-DI
3770024341DetectMM
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
Not 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

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)