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BIO-RAD LABORATORIOS BRASIL LTDA.

Brazil

✓ 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

22listed device types

Class I 11Class II 10Class III 0unclassified 1

plus 32 registration records and 319 510(k), 3 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 8Class II 10

161 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

36active device licences

Class II 30Class III 5Class IV 1

92 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 States32 registration records, 319 510(k), 3 PMA, 22 excluded

Brazil18 confirmed, 10 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada36 confirmed, 8 excluded

Manufacturer names merged into this page: BIO-RAD · BIO-RAD LABORATORIOS BRASIL LTDA · BIO-RAD LABORATORIOS BRASIL LTDA.

FDA 510(k) clearances by year

161993

71994

111995

101996

101997

331998

291999

152000

82001

132002

232003

82004

52005

12006

12007

32008

12010

22011

12012

12017

FDA listed device types

showing 8 of 22

Regulator, Temperature 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Calculator/Data Processing Module, For Clinical Use 1Culture Media, Non-Selective And Differential 1Reagents, Specific, Analyte 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Staphylococcus Aureus Protein A Insoluble 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171061	MRSASelect II	2017-12-28
US	K122187	VRESELECT CULTURE MEDIUM	2012-11-06
US	K103684	VRESELECT CULTURE MEDIUM	2011-10-21
BR	80020690139	Família de meios de cultura seletivos para determinado grupo de micro-	Class I
BR	80020690261	LAVADORA DE MICROPLACAS ELISA	Class I
BR	80020690291	Família Ágar Mueller-Hinton	Class II
CA	10249	DIAGNOSTICS PASTEUR THYROGLOBULIN IRMA PASTEUR KIT	Class II
CA	10250	PASTOREX CANDIDA	Class II
CA	10251	PLATELIA MYCOPLASMA PNEUMONIA IGG EIA KIT	Class II

BIO-RAD LABORATORIOS BRASIL LTDA.

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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