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Home›THE BINDING SITE BRASIL COMERCIO DE PRODUTOS PARA LABORATORIO LTDA

THE BINDING SITE BRASIL COMERCIO DE PRODUTOS PARA LABORATORIO LTDA

✓ 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
50listed device types
Class I 15Class II 35Class III 0
plus 169 registration records and 169 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
51registered devices
Class I 8Class II 43
65 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
151active device licences
Class II 151
163 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 States169 registration records, 169 510(k), 0 PMA
Brazil51 confirmed, 0 excluded
Canada151 confirmed, 0 excluded
Manufacturer names merged into this page: THE BINDING SITE · The Binding Site Group Ltd. · THE BINDING SITE, INC. · THE BINDING SITE GROUP LIMITED · THE BINDING SITE GROUP LTD · THE BINDING SITE BRASIL COMERCIO DE PRODUTOS PARA LABORATORIO LTDA
Same-named companies — This database also contains companies with near-identical names: THE BINDING SITE GROUP LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

142001
32002
62003
52004
32005
12006
22007
52008
42009
42010
32012
112013
62014
62015
42016
22017
42018
62019
12024
22025

FDA listed device types

showing 8 of 50
Antithrombin Iii Quantitation 1Calibrator, Secondary 1Test, Cystatin C 1Igal Heavy & Light Chain Combined 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1Complement C1q, Antigen, Antiserum, Control 1System, Test, C-Reactive Protein 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser2025-10-17
USK250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit2025-05-23
USK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit2024-01-24
BR81357320001Optilite IgG1 KitClass II
BR81357320002Optilite IgG KitClass II
BR81357320005Optilite Diluent 3Class I
CA18652AUTO ANTIBODIES SCREENING TESTSClass II
CA18653HUMAN IGG SUBCLASSES SINGLE DILUTION BINDARID KITSClass II
CA18654MONKEY OESOPHAGUS IFAClass II

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