Home›USA›BRAEMAR MANUFACTURING, LLC

BRAEMAR MANUFACTURING, LLC

USA · Eagan

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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

4listed device types

Class I 0Class II 4Class III 0

plus 8 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

18active device licences

Class II 18

19 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 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.

United States8 registration records, 3 510(k), 0 PMA, 2 excluded

Canada18 confirmed, 0 excluded

Manufacturer names merged into this page: BRAEMAR MANUFACTURING, LLC · Braemar Manufacturing, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171410	ePatch	2018-01-04
US	K153473	Braemar Telemetry Patch System	2016-07-22
US	K130294	BRAEMAR CARDIOKEY HOLTER RECORDER	2013-10-16
CA	69154	ER900 SERIES CARDIAC EVENT MONITOR	Class II
CA	69359	BRAEMAR DXP1000 SERIES DIGITAL HOLTER MONITOR	Class II
CA	69360	BRAEMAR DL800 SERIES DIGITAL HOLTER MONITOR	Class II

BRAEMAR MANUFACTURING, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies