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IceCure Medical , Ltd.

Israel · Caesarea

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 5 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 5 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: ICECURE MEDICAL LTD. · ICECURE MEDICAL LTD

FDA 510(k) clearances by year

12010 · K102360

12019 · K183213

12024 · K240892

12025 · DEN220077

12026 · K260377

FDA listed device types

Unit, Cryosurgical, Accessories 1Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer 1Instrument, Manual, Surgical, General Use 1Guide, Needle, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260377	XSense Cryoablation System with CryoProbes	2026-02-24
US	DEN220077	ProSense System	2025-10-03
US	K240892	XSense Cryoablation System with Cryoprobes	2024-06-28
BR	82155249002	Introdutor IceCure	Class II

IceCure Medical , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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