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Bladder Scanner

by Suzhou Peaksonic Medical Technology Co., Ltd. United States EUDAMED

Ref M3(without printer) M3(with printer)Model M3

EMDN Z12080304

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697512410M3WX Basic UDI-DIDate12 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
M3, M3(without printer) M3(with printer)
Primary DI / UDI-DI
06975124100445
Basic UDI-DI
697512410M3WX
Direct Marketing DI
06975124100445
EMDN Code
Z12080304 Ultrasonic bladder volume scanners
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000038246
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Suzhou Peaksonic Medical Technology Co., Ltd.

See all devices from Suzhou Peaksonic Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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

Sources (1)

  • EUDAMED 30c04429-3748-4994-be5c-cc433a637e73 61 fields · synced 23 Oct 2026