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Roche Diagnostics S.L.

Spain · Sant Cugat Del Valles Barcelona

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 8 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

276listed device types

Class I 72Class II 193Class III 4unclassified 7

plus 466 registration records and 485 510(k), 464 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

532registered devices

Class I 77Class II 455

797 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

88active device licences

Class II 72Class III 12Class IV 4

570 including historic records

TWTaiwanTFDA

583valid device licences

Class I 111Class II 452Class III 20

SGSingaporeHSA SMDR

333device registrations

CLASS B 197CLASS C 113CLASS D 23

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

96active ARTG entries

IVD Class 1 5IVD Class 2 22IVD Class 3 31IVD Class 4 37IIa 1

HKHong KongMDACS

260valid listings

IVD B 121IVD C 119IVD D 20

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 States466 registration records, 485 510(k), 464 PMA, 17 excluded

Brazil532 confirmed, 12 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada88 confirmed, 6 excluded

Manufacturer names merged into this page: ROCHE DIAGNOSTICS INTERNATIONAL LTD. · ROCHE DIAGNOSTICS GMBH · Roche Diagnostics Automation Solutions GmbH · Roche Diagnostics Santa Clara · ROCHE DIAGNOSTICS CORPORATION · ROCHE DIAGNOSTICS

FDA 510(k) clearances by year

192007

172008

162009

352010

192011

132012

142013

182014

92015

122016

122017

92018

52019

52020

42021

102022

72023

42024

72025

92026

FDA listed device types

showing 8 of 276

Turbidimetric, Total Protein 1Enzyme Immunoassay, Benzodiazepine 1Radioimmunoassay, Acth 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Electrode, Ion Specific, Urea Nitrogen 1Fluorescence Polarization Immunoassay, Carbamazepine 1Calibrator For Hemoglobin And Hematocrit Measurement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252323	cobas pulse blood glucose monitoring system	2026-06-12
US	K252431	Elecsys Calcitonin	2026-04-24
US	K252280	Elecsys Anti-SARS-CoV-2 S	2026-04-13
BR	10287411340	TT - Thrombin Time	Class II
BR	10287411341	CC 25mM (Calcium Chloride 25mM)	Class I
BR	10287411336	HIL Test	Class I
CA	999	ACCUCHEK EASY MONITOR SYSTEM	Class III
CA	2654	TRACER STRIPS	Class III
CA	2669	AMPLICOR ENTEROVIRUS	Class III

Roche Diagnostics S.L.

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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