Skip to content

Wireless Probe Type Ultrasound Scanner

by Guangzhou Sonostar Technologies Co., Ltd. 3 variants

Ref MD1202_5, MD1202_3, MD1202_2, MD1202_1, MD1202_6Model UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Nov 2029

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620203593-01 Date1 Jun 2026IssuedStatusActive expires 18 Nov 2029
United StatesGUDID listing GUDID Number06970672750050 UDI-DI Date1 Apr 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620203593-01 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    1 Jun 2026
    Expires
    18 Nov 2029
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Hand-held ultrasound imaging system, body-surface
Model / Reference
UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT EUDAMED
MD1202_5 EUDAMED
MD1202_3 EUDAMED
MD1202_2 EUDAMED
MD1202_1 EUDAMED
MD1202_6 EUDAMED
UProbe GUDID
Primary DI / UDI-DI
06970672750050, 06970672750036, 06970672750081, 06970672750029, 06970672750135
Basic UDI-DI
697067275WirelessProbeR7
510(k) Number
FDA Product Code
ITX, IYO
EMDN Code
Z11040106 Handheld ultrasound scanners
GMDN Term
Hand-held ultrasound imaging system, body-surface
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1560
EU market of registration
Germany
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT
MD1202_5
MD1202_3
MD1202_2
MD1202_1
MD1202_6
GUDID
UProbe
Device ClassEUDAMED
Class IIa
GUDID
Class II
Contains LatexEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000030303
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guangzhou Sonostar Technologies Co., Ltd.

See all devices from Guangzhou Sonostar Technologies Co., Ltd. →

Properties

  • Reusable
  • Contains Latex YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No