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High Intensity Focused Ultrasound System

by Shenzhen PRO HITU Medical Co., Ltd. EUDAMED

Active European Union

Ref MDD2022MA3375Model PRO2008

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975039130094 Basic UDI-DIDate13 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
PRO2008, MDD2022MA3375
Primary DI / UDI-DI
06975039130094
Basic UDI-DI
B-06975039130094
EMDN Code
Z120610 Ultrasound therapy equipment
Device Class
Class IIb
Market of Registration
Germany

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.

  • No

    Class IIb

  • No

    Class IIb

Properties

Show properties
  • 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