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NEOTRACT, INC.

USA · Pleasanton

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 7 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

2listed device types

Class I 0Class II 2Class III 0

plus 8 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

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 States8 registration records, 17 510(k), 0 PMA

Manufacturer names merged into this page: NEOTRACT, INC. · NEOTRACT, INC

FDA 510(k) clearances by year

12006

12008

22010

22013

22016

22017

22019

32020

12021

12023

FDA listed device types

Implantable Transprostatic Tissue Retractor System 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232558	UroLift 2 ATC Advanced Tissue Control System	2023-09-22
US	K212396	UroLift System Rigid Retrieval Kit Sterilization Tray	2021-10-22
US	K201837	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	2020-07-31

NEOTRACT, 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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