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NIPRO MEDICAL (HEFEI) CO LTD

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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

13listed device types

Class I 0Class II 13Class III 0

plus 28 registration records and 62 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

41registered devices

Class I 2Class II 39

48 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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

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 States28 registration records, 62 510(k), 0 PMA, 18 excluded

Brazil41 confirmed, 11 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: NIPRO MEDICAL CORPORATION · NIPRO MEDICAL LTDA · NIPRO MEDICAL (HEFEI) CO LTD

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 13

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 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Syringe, Piston 1System, Blood, Extracorporeal And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261399	ELISIO-HX	2026-07-28
US	K253047	PRESSONE	2026-03-24
US	K260533	ELISIO-H	2026-03-19
BR	10324860001	AGULHA HIPODERMICA NIPRO	Class II
BR	10324860002	AGULHA PARA FISTULA ARTERIO-VENOSA NIPRO	Class II
BR	10324860003	CATETER INTRA VENOSO NIPRO	Class II

NIPRO MEDICAL (HEFEI) CO LTD

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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