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ROCHE DIAGNOSTICA GMBH

Germany

✓ 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

272listed device types

Class I 72Class II 189Class III 4unclassified 7

plus 408 registration records and 458 510(k), 404 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

525registered devices

Class I 75Class II 450

1,184 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

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 States408 registration records, 458 510(k), 404 PMA, 28 excluded

Brazil525 confirmed, 15 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada88 confirmed, 6 excluded

Manufacturer names merged into this page: ROCHE DIAGNOSTICS GMBH · ROCHE DIAGNOSTICS CORPORATION · ROCHE DIAGNOSTICS · ROCHE DIAGNÓSTICA BRASIL LTDA · ROCHE DIAGNOSTICS - GMBH · ROCHE DIAGNOSTICS GMBH

FDA 510(k) clearances by year

192007

172008

162009

342010

192011

122012

112013

162014

62015

72016

102017

72018

42019

32020

42021

102022

72023

32024

62025

92026

FDA listed device types

showing 8 of 272

Turbidimetric, Total Protein 1Radioimmunoassay, Acth 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Enzyme Immunoassay, Benzodiazepine 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 DIAGNOSTICA GMBH

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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