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Cardio Flow Design Inc.

Japan · Tokyo · cfd.life

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 2 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

0UDI-DI device records

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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.

European Union2,575 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States3 registration records, 6 510(k), 0 PMA, 29 excluded

United Kingdom0 confirmed, 22 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: CARDIO FLOW DESIGN INC. · CARDIO FLOW, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250723	FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)	2025-04-25
US	K242947	FreedomFlow Orbital Circumferential Atherectomy System	2024-11-05
US	K233483	FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)	2024-02-15

Cardio Flow Design Inc.

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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