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GRAPHIC CONTROLS CORPORATION

USA · Buffalo

✓ Record-verifiedregistrations found in 4 markets

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

14listed device types

Class I 3Class II 10Class III 1

plus 24 registration records and 55 510(k), 3 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

26active device licences

Class II 24Class IV 2

31 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States24 registration records, 55 510(k), 3 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada26 confirmed, 0 excluded

Manufacturer names merged into this page: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies · GRAPHIC CONTROLS CORPORATION · GRAPHIC CONTROLS ACQUISITION CORP. D.B.A. NISSHA MEDICAL TECHNOLOGIES · Graphic Controls Ltd. · Graphic Controls Ltd. DBA Vermed · Graphic Controls Acquisition Corp.

FDA 510(k) clearances by year

21977

21978

21979

61980

11981

31982

11984

11985

11987

21989

11990

41991

11992

21993

21994

91995

81996

31997

41998

FDA listed device types

showing 8 of 14

Stimulator, Electrical, Evoked Response 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Piston Syringe Lever 1Dc-Defibrillator, Low-Energy, (Including Paddles) 1Plethysmograph, Impedance 1Tube, Tympanostomy 1Prosthesis, Nose, Internal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K981964	MEDI-TRACE 4103 NEONATAL ELECTRODE	1998-11-13
US	K983287	MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE	1998-11-05
US	K974730	SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)	1998-07-14
SA	ME0000004293SFDAA00001	Paper	—
SA	ME0000002181SFDAA00004	SilveRest	—
CA	11296	RADIOTRANSSLUCENT FOAM ELECTRODE	Class II
CA	4923	ECG MONITORING	Class II
CA	4942	MEDI-TRACE 1510M COMBINATION DEFIBRILLATION,PACING AND ECC ELECTRODE	Class IV

GRAPHIC CONTROLS CORPORATION

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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