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Ortho Diagnostics, Inc.

USA · Walker

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

199listed device types

Class I 67Class II 124Class III 0unclassified 8

plus 1,035 registration records and 169 510(k), 218 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

195registered devices

Class I 22Class II 173

348 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

51active device licences

Class II 39Class III 9Class IV 3

164 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 States1,035 registration records, 169 510(k), 218 PMA, 102 excluded

Brazil195 confirmed, 25 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada51 confirmed, 10 excluded

Manufacturer names merged into this page: ORTHO-CLINICAL DIAGNOSTICS, INC. · Ortho-Clinical Diagnostics, Inc. · Ortho-Clinical Diagnostics European Support Center · Ortho Clinical Diagnostics, K.K. · ORTHO-CLINICAL DIAGNOSTICS INC. · ORTHO-CLINICAL DIAGNOSTICS

Same-named companies — This database also contains companies with near-identical names: ORTHO CLINICAL DIAGNOSTIC, INC, ORTHO CLINICAL DIAGNÓSTICS , INC., ORTHO CLINICAL DIAGNOSTICS BIOTECHNOLOGY DEVELOPMENT (SHANGHAI) CO., LTD., ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

62005

192006

82007

42008

32009

22010

22012

32013

22015

32016

32017

22018

52019

12020

22021

32022

52023

22024

12025

12026

FDA listed device types

showing 8 of 199

Enzyme Immunoassay, Benzodiazepine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Complement C1q, Antigen, Antiserum, Control 1Starch-Dye Bound Polymer, Amylase 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1Enzymatic Radiochemical Assay, Tobramycin 1Enzyme Immunoassay, Diphenylhydantoin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254295	Sofia Lyme FIA; Sofia 2 Campylobacter FIA	2026-07-10
US	K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack	2025-10-29
US	K241534	VITROS Immunodiagnostic Products Syphilis Reagent Pack	2024-08-28
BR	10269410186	LAVADORA ORTHO AUTO WASH PLUS I/II	Class I
BR	81246986837	Família Produtos para Imunodiagnóstico VITROS Reagente e Calibrador	Class II
BR	81246986893	Família VITROS® Immunodiagnostic Products Intact PTH II Reagent Pack,	Class II
CA	11059	FETALSCREEN	Class III
CA	11348	ORTHO ANTIBODY TO HBSAG ELISA TEST SYSTEM 2	Class IV
CA	12985	ORTHO SICKLE CELL CONTROLS	Class II

Ortho 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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