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Home›USA›Wako Pure Chemical Industries, Ltd.

Wako Pure Chemical Industries, Ltd.

USA · Mchenry
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 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
12listed device types
Class I 5Class II 7Class III 0
plus 11 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class 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
14active device licences
Class II 14
25 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States11 registration records, 6 510(k), 0 PMA, 2 excluded
Brazil5 confirmed, 1 excluded
Canada14 confirmed, 0 excluded
Manufacturer names merged into this page: FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) · FUJIFILM WAKO PURE CHEMICAL CORPORATION
Same-named companies — This database also contains companies with near-identical names: FUJIFILM Wako Chemicals Europe GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mchenry

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

11979 · K791597
31980 · K801834
11981 · K813366
11984 · K842221

FDA listed device types

showing 8 of 12
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) 1System, Test, Low Density, Lipoprotein 1Titrimetric, Fatty Acids 1Ldl & Vldl Precipitation, Hdl 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Micro Total Analysis Instrument System 1Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma 1Calibrator, Secondary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK842221WAKO GLUCOSE C1984-07-12
USK813366AMMONIA TEST1981-12-22
USK801834WAKO HDL CHOLESTEROL TEST1980-09-16
BR80022069005Limulus Color KY (Multi teste)Class II
BR80022069006Limulus Color KY (Teste Único)Class II
BR80022069007PYROSTAR NeoClass II
CA65894AUTOKIT APO A1 (APOLIPOPROTEIN)Class II
CA65895AUTOKIT MICRO TP (TOTAL PROTEIN)Class II
CA65896AUTOKIT APO B (APOLIPOPROTEIN)Class II

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