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Nissha Medical Technologies (Ohio), Inc.

USA · Norwalk

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

33listed device types

Class I 6Class II 27Class III 0

plus 48 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

9 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 States48 registration records, 2 510(k), 0 PMA, 5 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: Nissha Medical Technologies (Ohio), Inc. · NISSHA MEDICAL TECHNOLOGIES SAS · Nissha Medical Technologies Limited · NISSHA MEDICAL TECHNOLOGIES LIMITED · NISSHA MEDICAL TECHNOLOGIES · Nissha Medical Technologies Ltd

FDA 510(k) clearances by year

22021 · K203350

FDA listed device types

showing 8 of 33

Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Laryngoscope, Rigid 1Forceps, General & Plastic Surgery 1Scissors, General, Surgical 1Surgical Instruments, G-U, Manual (And Accessories) 1Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203350	ENDOtube	2021-09-29
US	K203494	Nissha Medical Technologies Neutral Electrodes	2021-02-23
SA	ME0000004285SFDAA00001	ECG-Electrodes	—
SA	ME0000004137SFDAA00001	Radiolucent Defibrillation Electrode	—
CA	99564	TUB-ENDOPUMP TUBE FOR USE WITH IRRIGATION PUMP FOR ENDOSCOPE	Class II
CA	102869	ENDOTUBE	Class II

Nissha Medical Technologies (Ohio), Inc.

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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