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Gynetech Pty. , Ltd.

Australia · Pacifica

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 5

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 States0 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: Gynetech Pty Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150519	ManipulatOR PRO, ManipulatOR	2015-08-19
US	K142700	InsufflatOR Needle	2014-12-19
US	K142164	MANIPULATOR; MANIPULATOR PRO	2014-12-17
BR	80725210032	Manipulador Uterino ManipulatOR	Class II
BR	80725210033	Manipulador Uterino DUMI ManipulatOR	Class II
BR	80725210034	ColpotomizOR Tube System	Class II

Gynetech Pty. , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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