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BIO-RAD MEDICAL DIAGNOSTICS GMBH

Germany · Dreieich

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

29listed device types

Class I 12Class II 16Class III 0unclassified 1

plus 54 registration records and 319 510(k), 3 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 7Class II 10

43 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

38active device licences

Class II 30Class III 7Class IV 1

103 including historic records

TWTaiwanTFDA

26valid device licences

Class I 1Class II 23Class III 2

SGSingaporeHSA SMDR

9device registrations

CLASS C 8CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 3 5IVD Class 4 3

HKHong KongMDACS

15valid listings

IVD C 4IVD D 11

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

18active registrations

Class 2b 1Class 3 17

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 States54 registration records, 319 510(k), 3 PMA, 21 excluded

Brazil17 confirmed, 11 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada38 confirmed, 7 excluded

Manufacturer names merged into this page: BIO-RAD MEDICAL DIAGNOSTICS GMBH · BIO-RAD

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 29

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1Enzyme Linked Immunoabsorption Assay, Treponema Pallidum 1Blood Establishment Computer Software And Accessories 1Hepatitis A Test (Antibody And Igm Antibody) 1Test, Hiv Detection 1Media, Potentiating For In Vitro Diagnostic Use 1Enzyme Linked Immunoabsorbent Assay, Rubella 1System, Test, Automated Blood Grouping And Antibody 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