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Ultrasound Therapy

by Novin Electronics & Electrical Industries Engineering Co. Iran EUDAMED

Ref 4846Model US 215M EMDN Z120610

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06266779400029 Basic UDI-DIDate14 Oct 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Ultrasound Therapy
Model / Reference
US 215M, 4846
Primary DI / UDI-DI
06266779400029
Basic UDI-DI
B-06266779400029
EMDN Code
Z120610 Ultrasound therapy equipment
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
IR-MF-000044139
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: اولتراسوند تراپی

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: 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 8f2c6c1d-f2e0-49be-a548-85be49ee85f2 61 fields · synced 23 Oct 2026