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Rapid-Medical , Ltd.

USA · Yokneam Elite

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Russia — 8 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

7listed device types

Class I 0Class II 7Class III 0

plus 21 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2Class III 4

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States21 registration records, 10 510(k), 0 PMA, 28 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada1 confirmed, 6 excluded

Manufacturer names merged into this page: RAPID MEDICAL INC. · RAPID-MEDICAL LTD · RAPID MEDICAL LTD. · RAPID MEDICAL LTD

FDA 510(k) clearances by year

12019

12020

12021

12022

12023

22024

12025

22026

FDA listed device types

Guide, Wire, Catheter, Neurovasculature 1Wire, Guide, Catheter 1Catheter, Thrombus Retriever 1Temporary Embolization Assist Device, Peripheral 1Device, Neurovascular Embolization 1Device, Vascular, For Promoting Embolization 1Temporary Coil Embolization Assist Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254006	Drivewire 35 Guidewire	2026-07-17
US	K253062	Tigertriever 25 Revascularization Device	2026-03-12
US	K251603	Tigertriever 17 Ultra Revascularization Device	2025-10-06
CA	102838	COLUMBUS GUIDEWIRE	Class II

Rapid-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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