HomeFranceBio-Rad Service France SAS

Bio-Rad Service France SAS

France · Mitry Mory Ile-De
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Singapore — 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
23listed device types
Class I 12Class II 10Class III 0unclassified 1
plus 52 registration records and 319 510(k), 3 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
16registered devices
Class I 6Class II 10
41 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
36device registrations
CLASS B 7CLASS C 15CLASS D 14
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 States52 registration records, 319 510(k), 3 PMA, 21 excluded
Brazil16 confirmed, 12 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada36 confirmed, 8 excluded
Manufacturer names merged into this page: Bio-Rad Service France SAS · BIO-RAD

Company information

Country
France
City
Mitry Mory Ile-De

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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 23
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1Enzyme Linked Immunoabsorption Assay, Treponema Pallidum 1Hepatitis A Test (Antibody And Igm Antibody) 1Test, Hiv Detection 1Enzyme Linked Immunoabsorbent Assay, Rubella 1Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 1System, Test, Carcinoembryonic Antigen 1Assay, Glycosylated Hemoglobin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171061MRSASelect II2017-12-28
USK122187VRESELECT CULTURE MEDIUM2012-11-06
USK103684VRESELECT CULTURE MEDIUM2011-10-21
BR80020690139Família de meios de cultura seletivos para determinado grupo de micro-Class I
BR80020690261LAVADORA DE MICROPLACAS ELISAClass I
BR80020690291Família Ágar Mueller-HintonClass II
CA10249DIAGNOSTICS PASTEUR THYROGLOBULIN IRMA PASTEUR KITClass II
CA10250PASTOREX CANDIDAClass II
CA10251PLATELIA MYCOPLASMA PNEUMONIA IGG EIA KITClass II

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