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U. S. Diagnostics, Inc.

USA · San Luis Obispo

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

7listed device types

Class I 4Class II 2Class III 0unclassified 1

plus 7 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

0active device licences

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 States7 registration records, 25 510(k), 0 PMA, 611 excluded

Brazil2 confirmed, 200 excluded

Saudi Arabia0 confirmed, 8 excluded

Canada0 confirmed, 143 excluded

Manufacturer names merged into this page: Sun Diagnostics, LLC · O.N. DIAGNOSTICS, LLC · B&E DIAGNOSTICS INC.

FDA 510(k) clearances by year

81986

101987

12006

12007

12009

12011

12012

12018

12023

FDA listed device types

Container, Specimen Mailer And Storage, Non-Sterile 1General Purpose Reagent 1Reagents, Specific, Analyte 1Multi-Analyte Controls Unassayed 1Research Use Only/Immunology Devices 1System, Image Processing, Radiological 1Densitometer, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220402	VirtuOst	2023-05-19
US	K171435	VirtuOst Vertebral Fracture Assessment	2018-08-03
US	K113725	VIRTUOST	2012-09-13
BR	81154840006	Família de Analisadores Automáticos de Hematologia Hemax	Class II
BR	81154840007	Família de Analisadores Automáticos de Hematologia Hemax Série 300	Class II

U. S. Diagnostics, 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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