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AMERICAN DIAGNOSTIC CORPORATION

USA · Hauppauge

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel — 6 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

31listed device types

Class I 22Class II 8Class III 0unclassified 1

plus 72 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

8active device licences

Class II 6Class III 2

24 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States72 registration records, 39 510(k), 0 PMA, 175 excluded

Brazil0 confirmed, 41 excluded

Saudi Arabia5 confirmed, 3 excluded

Canada8 confirmed, 32 excluded

Manufacturer names merged into this page: AMERICAN DIAGNOSTIC CORP. · AMERICAN DIAGNOSTIC CORPORATION · American Diagnostic Corporation

FDA 510(k) clearances by year

51980

41981

121982

21983

31986

11987

41989

11993

21994

11997

12001

12006

12010

12017

FDA listed device types

showing 8 of 31

Ophthalmoscope, Battery-Powered 1System, Measurement, Blood-Pressure, Non-Invasive 1Flowmeter, Blood, Cardiovascular 1Clinical Electronic Thermometer 1Blood Pressure Cuff 1Oximeter 1Continuous Measurement Thermometer 1Stethoscope, Electronic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162589	Adscope 658 Electronic Stethoscope	2017-03-10
US	K093495	OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS	2010-11-19
US	K060321	ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK	2006-05-15
SA	ME0000007609SFDAA00005	Diagnostix 5110N Pocket Diagnostic Set	—
SA	ME0000007609SFDAA00001	Adscope™ Clinician Series Stethoscope	—
CA	69461	BLOOD PRESSURE MONITORS	Class II
CA	84813	ADVIEW 9000 MODULAR DIAGNOSTIC STATION SPO2 MODULE	Class III
CA	84814	ADVIEW 9000 MODULAR DIAGNOSTIC STATION (INCLUDING BP, SPO2, AND TEMPERATURE MODULES)	Class III

AMERICAN DIAGNOSTIC 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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