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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
  • Suzhou Leapmed Healthcare Corporation

Data from EUDAMED, last updated Jun 11, 2026

Ultrasound Biopsy Kits

69411650000000627D

3 references

Class I
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class I
Manufacturer
Suzhou Leapmed Healthcare Corporation

Device family identification

Device name
Ultrasound Biopsy Kits
Basic UDI-DI
69411650000000627D
Device model
LPUBK07
Issuing agency
GS1
Version date
May 11, 2026

Classification

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

Manufacturer & authorised representative

Manufacturer

Name
Suzhou Leapmed Healthcare Corporation
SRN
CN-MF-000013964
Country
China
Email
zhuyu@leapmed.com

Authorised representative

Name
RIOMAVIX SOCIEDAD LIMITADA
SRN
ES-AR-000001202
Country
Spain

Device characteristics

No device characteristics flagged

EMDN code(s)

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

  • Z11049085Various ultrasound instruments - consumables

References by status

References

3 references

Export results

Applied filters

  • basicUdiUlid·01KRATTT3AMY3NFHQGCD9TZBJM

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
Ultrasound Biopsy Kits10652102069411650049051On the market
Ultrasound Biopsy Kits10650602069411650048131On the market
Ultrasound Biopsy Kits10653002069411650037001On the market