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IceForce™

by Boston Scientific Corporation United States EUDAMED

Ref H7493963736050

EMDN Z120102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000547NK Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Cryoablation Prostate Kits (Procedure Packs)
Model / Reference
H7493963736050
Primary DI / UDI-DI
00191506017040
Basic UDI-DI
01915060000000000000547NK
EMDN Code
Z120102 Cryosurgery equipment
Device Class
Class IIb
Medical Purpose
"The ICEfx Cryoablation System and Visual-ICE Cryoablation System (used in conjunction with Boston Scientific accessory products) are intended to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures during minimally invasive procedures. The clinical benefit is measured by overall clinical outcomes with acceptable safety specific to the target anatomy and indication. "

Manufacturer details

EUDAMED SRN
US-PR-000008885

Other devices from Boston Scientific

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 00191506017040|01915060000000000000547NK 61 fields · synced 24 Oct 2026