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ARKRAY Industry West Inc.

Philippines · Rosario Cavite
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 2 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
8listed device types
Class I 2Class II 6Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
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 States10 registration records, 0 510(k), 0 PMA, 7 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: ARKRAY Industry West Inc. · ARKRAY INDUSTRY INC.
Same-named companies — This database also contains companies with near-identical names: ARKRAY INDUSTRY INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Philippines
City
Rosario Cavite

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 listed device types

Prescription Use Blood Glucose Meter For Near-Patient Testing 1Glucose Oxidase, Glucose 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Calibrator, Surrogate 1Multiple Use Blood Lancet For Single Patient Use Only 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Urinalysis Controls (Assayed And Unassayed) 1

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