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TORAX MEDICAL, INC.

USA · Cincinnati

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Singapore, Australia, Hong Kong, Israel — 5 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

4listed device types

Class I 0Class II 1Class III 2unclassified 1

plus 4 registration records and 2 510(k), 41 PMA

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

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States4 registration records, 2 510(k), 41 PMA

Manufacturer names merged into this page: TORAX MEDICAL, INC.

FDA 510(k) clearances by year

12020 · K201035

12023 · K230089

FDA listed device types

Laparoscopic Accessories, Esophageal Sizing 1Implanted Fecal Incontinence Device 1Implant, Anti-Gastroesophageal Reflux 1Mechanical Compression Device Fecal Incontinence (Non-Manually Operated) 1

Market	Identifier	Name	Class / date
US	K230089	ETHICON LINX® Esophagus Sizing Tool	2023-02-09
US	K201035	ETHICON Linx Esophagus Sizing Tool	2020-07-09

TORAX MEDICAL, 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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