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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • SONOSCAPE MEDICAL CORP.

Data from EUDAMED, last updated Jun 11, 2026

Digital Color Doppler ultrasound System

69458686U1024SM

17 references

Class IIa
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Manufacturer
SONOSCAPE MEDICAL CORP.

Device family identification

Device name
Digital Color Doppler ultrasound System
Basic UDI-DI
69458686U1024SM
Device model
X11 Exp
Issuing agency
GS1
Version date
May 13, 2025

Classification

Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
SONOSCAPE MEDICAL CORP.
SRN
CN-MF-000009623
Country
China
Email
ra@sonoscape.net
Phone
+86-755-26722890

Authorised representative

Name
Shanghai International Holding Corp. GmbH(Europe)
SRN
DE-AR-000000001
Country
Germany
Phone
+49 40 2513175

Device characteristics

Active deviceMeasuring function

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • Z11040103Portable ultrasound scanners

References by status

References

17 references

Export results

Applied filters

  • basicUdiUlid·01JV46GHH4B8XRXQ0ES1SYTG6Q

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
E12_069458686158881On the market
E12 Exp_069458686158951On the market
ER9_069458686159631On the market
HE_069458686159491On the market
HE Senior_069458686159561On the market
HE12_069458686159251On the market
HE12 Elite_069458686159321On the market
HX_069458686158571On the market
HX Senior_069458686158641On the market
HX12_069458686158261On the market
HX12 Elite_069458686158401On the market
HX12 Exp_069458686158331On the market
X12_069458686157891On the market
X12 Elite_069458686158021On the market
X12 Exp_069458686157961On the market
X12 Pro_069458686158191On the market
XR9_069458686158711On the market