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NIPRO CORPORATION LIMITED

Japan · Settsu

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

24listed device types

Class I 6Class II 18Class III 0

plus 48 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 7

36 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

43device registrations

CLASS B 30CLASS C 11CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

Class III 1IIa 10IIb 5Class Is (sterile) 2

HKHong KongMDACS

6valid listings

Class II 1Class III 3Class IV 2

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

17active registrations

Class 2a 6Class 2b 8Class 3 3

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 States48 registration records, 1 510(k), 0 PMA, 19 excluded

Brazil8 confirmed, 11 excluded

Canada7 confirmed, 2 excluded

Manufacturer names merged into this page: NIPRO CORPORATION · NIPRO CORPORATION LIMITED

Business registration

Legal name: NIPRO CORPORATION
Corporate Number: 8120001068678
Registration status: Active
Registered capital: JPY 84,397,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11985 · K854479

FDA listed device types

showing 8 of 24

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 1Endoscopic Guidewire, Gastroenterology-Urology 1Wire, Guide, Catheter 1Protector, Transducer, Dialysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K854479	BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH	1985-12-16
BR	80788629007	Agulha para coleta de sangue Nipro	Class II
BR	80145240415	PLASTER BANDAGEM ADESIVA	Class II
BR	10324860091	HEMOCONCENTRADOR BHC	Class II
CA	69071	ARTERIAL VENOUS FISTULA NEEDLE	Class II
CA	69072	AQUALINER HYDROPHILIC GUIDE WIRE	Class II
CA	74730	GLUCOPRO LANCETS	Class II