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TRANSONIC SYSTEMS, INC.

USA · Ithaca

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, 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

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 5 registration records and 16 510(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

2active device licences

Class II 1Class III 1

6 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class III 1IIb 3

HKHong KongMDACS

3valid listings

Class II 2Class IV 1

ILIsraelAMAR

5registrations

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 States5 registration records, 16 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: TRANSONIC SYSTEMS, INC. · TRANSONIC SYSTEMS INC.

FDA 510(k) clearances by year

11988

11990

11997

11998

12000

32002

12003

12008

12011

12012

22014

22015

FDA listed device types

Flowmeter, Blood, Cardiovascular 1System, Hemodialysis, Access Recirculation Monitoring 1Computer, Diagnostic, Pre-Programmed, Single-Function 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K140740	TRANSONIC TISSUE PERFUSION MONITOR	2015-07-23
US	K134051	TRANSONIC ELSA SYSTEM	2015-01-29
US	K134035	TRANSONIC HCM 103 SYSTEM	2014-09-17
CA	71097	REOCATH HVT100	Class II
CA	89209	COSTATUS CARDIAC FUNCTION & BLOOD VOLUME MEASUREMENT SYSTEM	Class III

TRANSONIC SYSTEMS, 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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