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Nakanishi, Inc.

Japan · Kanuma-Shi

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

23listed device types

Class I 14Class II 8Class III 0unclassified 1

plus 67 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

15active device licences

Class II 15

86 including historic records

TWTaiwanTFDA

19valid device licences

Class I 9Class II 10

SGSingaporeHSA SMDR

60device registrations

CLASS B 60

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

45active ARTG entries

Class I 4IIa 41

HKHong KongMDACS

13valid listings

Class II 13

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

27active registrations

Class 2a 27

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 States67 registration records, 40 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 2 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: NAKANISHI INC.

Business registration

Legal name: NAKANISHI INC.
Corporate Number: 1060001010545
Registration status: Active
Registered capital: JPY 867,000,000

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

12001

12002

12003

12004

12007

32008

22009

42012

52013

42017

12018

12019

12020

22021

22022

22023

42024

32025

12026

FDA listed device types

showing 8 of 23

Motor, Surgical Instrument, Ac-Powered 1Controller, Foot, Handpiece And Cord 1Handpiece, Direct Drive, Ac-Powered 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Air-Powered, Dental 1Bur, Surgical, General & Plastic Surgery 1Bur, Ear, Nose And Throat 1Saw, Electrically Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260773	Varios Combi Pro2	2026-03-10
US	K254163	VarioSurg 4	2025-12-23
US	K251689	VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)	2025-09-19
BR	10234370067	Brocas Cirúrgicas de Carbide para Sistema para Microcirurgia Primado I	Class I
CA	37416	ALL TITANIUM BOBY MICROMOTOR SYSTEM TI-MAX EL400	Class II
CA	37434	STRAIGHT AND GEARED ANGLE HANDPIECE	Class II
CA	37588	MICROMOTOR MD SET	Class II