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No

by Shenzhen PRO HITU Medical Co., Ltd. China EUDAMED

Ref PRO300

EMDN Z120610

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975039130018 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
High intensity focused ultrasound systems
Model / Reference
PRO300
Primary DI / UDI-DI
06975039130018
Basic UDI-DI
B-06975039130018
EMDN Code
Z120610 Ultrasound therapy equipment
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000021578
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen PRO HITU Medical Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ce3134e2-7306-439c-aa44-9bb7be3c238e 61 fields · synced 24 Oct 2026