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Gynex Corporation

USA · North Richland Hills

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

44listed device types

Class I 30Class II 14Class III 0

plus 44 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

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 States44 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: Gynex Corporation

FDA 510(k) clearances by year

31998 · K980238

11999 · K982739

12006 · K061306

FDA listed device types

showing 8 of 44

Electrosurgical, Cutting & Coagulation & Accessories 1Electrosurgical Patient Return Electrode 1Set, Anesthesia, Paracervical 1Electrocautery, Gynecologic (And Accessories) 1Colposcope (And Colpomicroscope) 1Colposcope (And Colpomicroscope), Exempt 1Monitor, Ultrasonic, Fetal 1Curette, Suction, Endometrial (And Accessories) 1

Market	Identifier	Name	Class / date
US	K061306	CO-1000 COLPOSCOPE, MULTIPLE	2006-08-07
US	K982739	GYNEX ELECTRODES	1999-03-12
US	K980238	GYNEX EXTENDED REACH NEEDLE	1998-08-21

Gynex 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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