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MEDICOMP, INC.

USA · Melbourne

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Taiwan — 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

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

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, 23 510(k), 0 PMA, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: MEDICOMP, INC. · medicomp

FDA 510(k) clearances by year

11983

21984

21985

41986

21987

31988

11990

11994

11995

11998

12005

22009

12016

12018

FDA listed device types

Electrocardiograph, Ambulatory, With Analysis Algorithm 1Detector And Alarm, Arrhythmia 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173170	Epicardia Anywhere	2018-01-10
US	K161916	TelePatch Cardiac Monitor	2016-12-21
US	K091696	SAVI WIRELESS, MODEL PM500	2009-10-26
SA	ME0000000483SFDAA00001	MEDICOMP Manual Percussor	—
SA	ME0000000483SFDAA00003	Medicomp connector	—

MEDICOMP, 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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