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NIPRO MEDICAL CORPORATION

USA · Miami
✓ 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
20listed device types
Class I 5Class II 15Class III 0
plus 44 registration records and 62 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
45registered devices
Class I 3Class II 42
61 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
15 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 States44 registration records, 62 510(k), 0 PMA, 17 excluded
Brazil45 confirmed, 8 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: NIPRO MEDICAL CORPORATION · NIPRO MEDICAL INDUSTRIES LTD. · NIPRO MEDICAL LTDA · NIPRO MEDICAL INDUSTRIES LTDA · NIPRO MEDICAL CORPORATION PRODUTOS MÉDICOS LTDA · NIPRO MEDICAL INDUSTRIES LTD
Same-named companies — This database also contains companies with near-identical names: NIPRO MEDICAL INDUSTRIES LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Miami

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

52001
12002
22003
12004
32005
12006
42007
22008
22009
22010
62012
82013
22014
12016
22017
12018
32019
12022
12023
32026

FDA listed device types

showing 8 of 20
Hemodialyzer With Expanded Solute Removal Profile 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Needle, Fistula 1Catheter, Hemodialysis, Non-Implanted 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Wire, Guide, Catheter 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261399ELISIO™-HX2026-07-28
USK253047PRESSONE™2026-03-24
USK260533ELISIO™-H2026-03-19
BR10324860001AGULHA HIPODERMICA NIPROClass II
BR10324860002AGULHA PARA FISTULA ARTERIO-VENOSA NIPROClass II
BR10324860003CATETER INTRA VENOSO NIPROClass II

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