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Heart Technology, Inc.

USA · Bellevue

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 3Class II 3Class III 0unclassified 1

plus 7 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered 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

pendingnot queried

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.

United States7 registration records, 8 510(k), 0 PMA, 32 excluded

Brazil0 confirmed, 7 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD. · Beijing Sea Heart international science and Technology Co.,Ltd

Same-named companies — This database also contains companies with near-identical names: BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11990

11991

11992

11993

11995

21996

12018

FDA listed device types

Powered Laser Surgical Instrument 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Massager, Therapeutic, Electric 1Device, Pressure Applying 1Brush, Dermabrasion, Manual 1Static Electricity-Emitting Device, Cosmetic Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172616	Pulse Oximeter	2018-07-27
US	K960379	ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE	1996-04-25
US	K954604	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY	1996-01-18
SA	ME0000007900SFDAA00003	Hydra Master SPA20	—

Heart Technology, 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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