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Sentreheart, Inc.

USA · Redwood City

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

5active device licences

Class II 4Class III 1

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 States0 registration records, 6 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: SENTREHEART INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K153096	LARIAT RS Suture Delivery Device	2015-11-25
US	K142241	LARIAT sulture Delivery Device	2014-09-12
US	K090385	LARIAT II SUTURE DELIVERY DEVICE	2009-05-06
CA	75781	OCCLUSION BALLOON CATHETER	Class II
CA	76488	FINDRWIRZ GUIDE WIRE SYSTEM	Class II
CA	82564	LARIAT SUTURE DELIVERY DEVICE	Class III

Sentreheart, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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