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Wireless Probe Type Ultrasound Scanner

by Guangzhou Sonostar Technologies Co., Ltd. United States EUDAMEDGUDID

Ref MD1202_4Model UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT Product code IYOEMDN Z11040106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620203593-01 Date1 Jun 2026IssuedStatusActive expires 18 Nov 2029
United StatesGUDID listing GUDID Number06970672750043 UDI-DIDate1 Apr 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620203593-01 Supplemented

    Quality management system EU MDR

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

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Bladder ultrasound imaging transducer
Model / Reference
UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT EUDAMED
MD1202_4 EUDAMED
BProbe GUDID
Primary DI / UDI-DI
06970672750043
Basic UDI-DI
697067275WirelessProbeR7
510(k) Number
FDA Product Code
IYO, ITX
EMDN Code
Z11040106 Handheld ultrasound scanners
GMDN Term
Bladder ultrasound imaging transducer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1570
Market of Registration
Germany
Commercial Distribution
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_4
GUDID
BProbe
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.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED ad891a34-940f-406d-b65a-5706d39fe014 61 fields · synced 22 Oct 2026
  • FDA UDI 0d2c4cb3-87ef-47f6-90ee-c1f943b4372b 33 fields · synced 30 May 2026