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Home›USA›North East Monitoring, Inc.

North East Monitoring, Inc.

USA · Shelton
✓ 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
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 10 510(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 5
15 including historic records
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 States3 registration records, 10 510(k), 0 PMA, 34 excluded
Brazil0 confirmed, 1 excluded
Canada5 confirmed, 5 excluded
Manufacturer names merged into this page: NORTHEAST MONITORING, INC.

Company information

Country
USA
City
Shelton

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11995
11996
11999
12000
12001
12004
12006
12007
12008
12014

FDA listed device types

Computer, Diagnostic, Programmable 1Electrocardiograph, Ambulatory (Without Analysis) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK142424DR300 HOLTER MONITOR2014-11-25
USK081861HOLTER LX ANALYSIS2008-12-04
USK070014AUTO DETECT FOR TELAHEART DR200/E-A2007-05-25
CA64247DR180+ OXY HOLTERClass II
CA64248DR180+ DIGITAL RECORDERClass II
CA66487SD360 DIGITAL RECORDERClass II

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