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Universal Medical Instrument Corp.

USA · Walker

✓ 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

29510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 29 510(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

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

0valid device licences

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, 29 510(k), 0 PMA, 44 excluded

Brazil0 confirmed, 4 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: UNIVERSAL MEDICAL INC.

Same-named companies — This database also contains companies with near-identical names: Changzhou Universal Medical Equipment Co., Ltd., Nanjing Universal Medical Equipment Co., Ltd., Universal Medical Products, Inc., Universal Medical Technologies. Company name alone cannot separate their registrations, so the figures below may include either.

Market	Identifier	Name	Class / date
US	K083535	HEARTRAK SMART ECAT	2008-12-15
US	K071130	HEARTRAK AF	2008-05-14
US	K033451	HEARTRAK SMART AT/HEARTRAK SMART2	2004-02-05
CA	9235	HEARTRAK	Class II

Universal Medical Instrument Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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