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GRAPHIC CONTROLS ACQUISITION CORP. D.B.A. NISSHA MEDICAL TECHNOLOGIES

USA · Buffalo

✓ 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

21listed device types

Class I 3Class II 17Class III 1

plus 31 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

4active device licences

Class II 4

16 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 States31 registration records, 2 510(k), 0 PMA, 5 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: NISSHA MEDICAL TECHNOLOGIES SAS · Graphic Controls Acquisition Corp.dba Nissha Medical Technologies · Nissha Medical Technologies Limited · GRAPHIC CONTROLS ACQUISITION CORP. D.B.A. NISSHA MEDICAL TECHNOLOGIES · NISSHA MEDICAL TECHNOLOGIES LIMITED · NISSHA MEDICAL TECHNOLOGIES

FDA 510(k) clearances by year

22021 · K203350

FDA listed device types

showing 8 of 21

Electrosurgical, Cutting & Coagulation & Accessories 1Burst Suppression Detection Software For Electroencephalograph 1Stimulator, Electrical, Evoked Response 1Probe, Radiofrequency Lesion 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Dc-Defibrillator, Low-Energy, (Including Paddles) 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
CA	94184	VERMED DEFIBRILLATION ELECTRODES	Class II

GRAPHIC CONTROLS ACQUISITION CORP. D.B.A. NISSHA MEDICAL TECHNOLOGIES

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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