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Coagusense, Inc.

USA · Fremont

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 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

3listed device types

Class I 0Class II 3Class III 0

plus 5 registration records and 3 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States5 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: COAGUSENSE INC

FDA 510(k) clearances by year

12010 · K093243

12019 · K183255

12022 · K212779

FDA listed device types

System, Multipurpose For In Vitro Coagulation Studies 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Test, Time, Prothrombin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212779	Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing	2022-10-05
US	K183255	Coag-Sense Prothrombin Time (PT) / INR Monitoring Device	2019-02-21
US	K093243	COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM	2010-04-07

Coagusense, 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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