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P4-12

by Sonoscape Medical Corp.

Part of a family of 7 devices: see the family page

Ref _Model 8P1

P4-12 (_) is a Class IIa device made by Sonoscape Medical Corp., registered in EUDAMED on 23 Sep 2023 (Basic UDI-DI 69458686P1012QP), 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 Number69458686P1012QP Basic UDI-DI 06945868617219UDI-DIDate23 Sep 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Ultrasonic Transducer
Model / reference
8P1, _
Primary DI / UDI-DI
06945868617219
Basic UDI-DI
69458686P1012QP
Direct marketing DI
06945868617219
EMDN code
Z110402010301 Transcutaneous ultrasound sector probes (phased array), two–dimensional
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

Similar devices in this category

Other devices filed under TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL.

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

Other properties (14, all answered No)