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P11 Elite

by Sonoscape Medical Corp.

Part of a family of 16 devices: see the family page

Model P12 Elite

P11 Elite (P12 Elite) is a Class IIa device made by Sonoscape Medical Corp., registered in EUDAMED on 28 Sep 2023 (Basic UDI-DI 69458686U1015SL), 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 Number69458686U1015SL Basic UDI-DI 06945868607180UDI-DIDate28 Sep 2023RegisteredStatusActive

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  • Withdrawn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
P12 Elite
Primary DI / UDI-DI
06945868607180
Basic UDI-DI
69458686U1015SL
EMDN code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
Device class
Class IIa
System or procedure pack
System which is a device in itself
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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Properties

Other properties (14, all answered No)