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Home›USA›ARKRAY FACTORY USA, INC.

ARKRAY FACTORY USA, INC.

USA · Minneapolis
✓ 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
32listed device types
Class I 15Class II 17Class III 0
plus 52 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
45registered devices
Class I 10Class II 35
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
10active device licences
Class II 9Class III 1
22 including historic records
TWTaiwanTFDA
0valid device licences
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 States52 registration records, 16 510(k), 0 PMA, 4 excluded
Brazil45 confirmed, 0 excluded
Canada10 confirmed, 0 excluded
Manufacturer names merged into this page: ARKRAY FACTORY USA, INC. · ARKRAY Factory, Inc. · ARKRAY FACTORY, INC. · ARKRAY FACTORY INC
Same-named companies — This database also contains companies with near-identical names: ARKRAY Factory, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Minneapolis

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

12006
12007
22008
42009
12010
12011
32014
22017
12019

FDA listed device types

showing 8 of 32
Prescription Use Blood Glucose Meter For Near-Patient Testing 1Counter, Differential Cell 1Hemoglobin A1c Test System 1Glucose Oxidase, Glucose 1Blood, Occult, Colorimetric, In Urine 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Calibrator, Secondary 1Counter, Urine Particle 1

Registration details (sample)

MarketIdentifierNameClass / date
USK183306GLUCOCARD® W onyx Blood Glucose Monitoring System2019-04-10
USK170064GLUCOCARD W Blood Glucose Monitoring System2017-08-16
USK162822ADAMS A1c HA-8180V, CALIBRATOR 802017-06-29
BR82444370368ELUENT 90CVClass I
BR82444370373CALIBRATOR 90Class II
BR82444370374Automatic Glycohemoglobin Analyzer ADAMS A1c HA-8190VClass II
CA1988DIASCREEN REAGENT STRIPS FOR URINALYSISClass II
CA35067DIASCREEN 50 URINE CHEMISTRY ANALYZERClass II
CA60099TECHLITE LANCETSClass II

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