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X12

by Sonoscape Medical Corp.

Part of a family of 116 devices: see the family page

Ref _Model X11 Exp

X12 (_) is a Class IIa device made by Sonoscape Medical Corp., registered in EUDAMED on 13 May 2025 (Basic UDI-DI 69458686U1024SM), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69458686U1024SM Basic UDI-DI 06945868615789UDI-DIDate13 May 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Digital Color Doppler ultrasound System
Model / reference
X11 Exp, _
Primary DI / UDI-DI
06945868615789
Basic UDI-DI
69458686U1024SM
EMDN code
Z11040103 Portable ultrasound scanners
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009623
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Other devices filed under PORTABLE ULTRASOUND SCANNERS.

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Properties

  • Measuring function
Other properties (13, all answered No)