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MedGyn Products Inc.

USA · Westmont IL · www.medgyn.com

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 8 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

0UDI-DI device records

USUnited StatesFDA openFDA

40listed device types

Class I 13Class II 27Class III 0

plus 64 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

10registered devices

Class I 5Class II 5

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

29 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

48active ARTG entries

Class I 10IIa 20IIb 1Class Is (sterile) 17

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

11registrations

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.

European Union297 raw hits, 297 excluded, 0 confirmed

United States64 registration records, 5 510(k), 0 PMA

United Kingdom0 confirmed, 1 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Manufacturer names merged into this page: MEDGYN PRODUCTS, INC. · MEDGYN PRODUCTS INTERNATIONAL INC AND MEDGYN PRODUCTS, INC. · MEDGYN PRODUCTS INC

FDA 510(k) clearances by year

21988 · K880196

11995 · K945179

12013 · K122973

12015 · K143669

FDA listed device types

showing 8 of 40

Needle, Assisted Reproduction 1Spatula, Cervical, Cytological 1Bottle, Collection, Vacuum 1Catheter, Assisted Reproduction 1System, Imaging, Pulsed Doppler, Ultrasonic 1Source, Abortion Unit, Vacuum 1Colposcope (And Colpomicroscope) 1Pump, Portable, Aspiration (Manual Or Powered) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter	2015-11-23
US	K122973	AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE	2013-06-12
US	K945179	BOTTLE COLLECTION SET	1995-01-26
BR	80718470024	ENDOSAMPLER-COLETOR DE AMOSTRAS ENDOMÉTRIO	Class II
BR	80718470025	KIT DE ASPIRAÇÃO	Class I
BR	10289680194	Cateter para histerossalpingografia Medgyn	Class II
SA	ME0000005739SFDAA00025	Colposcopy Instrument Set	—
SA	ME0000005739SFDAA00030	Lletz Pederson Speculum	—

MedGyn Products 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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