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Roche Diagnostics/Boehringer Mannheim GmbH

USA · Pleasanton

✓ 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

346510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 346 510(k), 5 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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 States0 registration records, 346 510(k), 5 PMA

Brazil7 confirmed, 1 excluded

Manufacturer names merged into this page: ROCHE DIAGNOSTICS GMBH (MANNHEIM)

Registration details (sample)

Market	Identifier	Name	Class / date
US	K983892	COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P	1999-04-13
US	K984326	ELECYS IGE ASSAY	1999-02-08
US	K983047	ACCU-CHEK HQ SYSTEM	1999-02-05
BR	10287411164	Reagentes Genéricos Cobas 4800 System	Class I
BR	10287410662	PHOS2 - PHOSPHAT C111	Class II
BR	10287411517	PPX (ONLINE DAT Propoxyphene Plus)_cobas c	Class II

Roche Diagnostics/Boehringer Mannheim GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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