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Roche Diagnostic Systems, Inc.

USA · Branchburg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Hong Kong — 4 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

296510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 296 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active device licences

Class III 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

IVD B 1

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 States0 registration records, 296 510(k), 0 PMA, 32 excluded

Brazil0 confirmed, 23 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 8 excluded

Manufacturer names merged into this page: ROCHE DIAGNOSTIC SYSTEMS, INC., A MEMBER OF THE ROCHE GROUP

Same-named companies — This database also contains companies with near-identical names: ROCHE DIAGNOSTIC SYSTEMS, INC., A MEMBER OF THE ROCHE GROUP. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K983698	MODIFICATION TO ABUSCREEN ONLINE BARBITURATES	1999-05-03
US	K983702	MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES	1999-02-11
US	K983704	MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE	1999-02-10
CA	2660	AMPLICOR MYCOBACTERIUM AVIUM/INTRACELLULARE (MAI)	Class III

Roche Diagnostic Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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