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The ScottCare Corporation

USA · Cleveland

✓ 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

9listed device types

Class I 0Class II 9Class III 0

plus 12 registration records and 7 510(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

17active device licences

Class II 17

20 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 States12 registration records, 7 510(k), 0 PMA

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: SCOTTCARE CORPORATION

FDA 510(k) clearances by year

11990

12005

12008

12009

12010

12014

12025

FDA listed device types

showing 8 of 9

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Transmitters And Receivers, Electrocardiograph, Telephone 1Computer, Blood-Pressure 1Computer, Diagnostic, Programmable 1Recorder, Magnetic Tape, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250259	TeleRehab Aermos Cardiopulmonary Rehabilitation	2025-06-04
US	K142180	TELESENSE	2014-12-12
US	K092947	TELESENTRY, MODEL TS01	2010-02-26
CA	103802	ABPCARE	Class II
CA	103880	ARRIO	Class II
CA	103959	ECG RECEIVING MODULE	Class II

The ScottCare Corporation

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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