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C613

by Sonoscape Medical Corp. 6 variants

Part of a family of 9 devices: see the family page

Ref /Model C613

C613 is a device classified as Class IIa in the EU and Class II in the US made by Sonoscape Medical Corp., registered in EUDAMED on 9 Sep 2023 (Basic UDI-DI 69458686P1007QW), cleared under FDA 510(k) K170999 on 12 Jul 2017 and listed in FDA GUDID since 14 Sep 2017 (UDI-DI 06945868601942), 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) K170999

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 Number69458686P1007QW Basic UDI-DI 06945868601942UDI-DIDate9 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06945868601942 UDI-DI Date14 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170999 Date12 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69458686P1007QW registered 9 Sep 2023 Active
  • FDA 510(k) K170999 decided 12 Jul 2017 Active
  • FDA GUDID UDI-DI 06945868601942 listed 14 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170999
  2. Listed FDA GUDID 06945868601942
  3. Registered EUDAMED 69458686P1007QW

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  • Withdrawn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
C613 EUDAMED
Sonoscape GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
Ultrasonic Transducer
Model / reference
C613, /
Primary DI / UDI-DI
06945868601942
Basic UDI-DI
69458686P1007QW
Direct marketing DI
06945868601942
510(k) Number
FDA product code
ITX, IYN, IYO
EMDN code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1550, 892.1560
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

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY).

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)