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P60 Exp

by Sonoscape Medical Corp.

Model P60 Exp

P60 Exp is a general-purpose ultrasound imaging system (EU MDR Class IIa; FDA Class II) made by Sonoscape Medical Corp., registered in EUDAMED on 1 Jun 2023 (Basic UDI-DI 69458686U1001S9), cleared under FDA 510(k) K171000 on 11 Jul 2017 and listed in FDA GUDID since 27 Oct 2017 (UDI-DI 06945868616052), 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) K171000

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69458686U1001S9 Basic UDI-DI 06945868616052UDI-DIDate1 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945868616052 UDI-DI Date27 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171000 Date11 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69458686U1001S9 registered 1 Jun 2023 Active
  • FDA 510(k) K171000 decided 11 Jul 2017 Active
  • FDA GUDID UDI-DI 06945868616052 listed 27 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171000
  2. Listed FDA GUDID 06945868616052
  3. Registered EUDAMED 69458686U1001S9

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  • Withdrawn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

Trade name
P60 Exp EUDAMED
Sonoscape GUDID
Generic name
General-purpose ultrasound imaging system
Model / reference
P60 Exp
Primary DI / UDI-DI
06945868616052
Basic UDI-DI
69458686U1001S9
510(k) Number
FDA product code
IYN, IYO, ITX
EMDN code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1560, 892.1570
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

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

Similar devices in this category

Other devices filed under MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.).

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)