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ClearStream Technologies , Ltd.

Ireland · Enniscorthy

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

7listed device types

Class I 0Class II 5Class III 2

plus 16 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class IV 2

9 including historic records

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

3device registrations

CLASS C 1CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

Class III 1IIa 1IIb 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 1Class 3 6

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 States16 registration records, 7 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: CLEARSTREAM TECHNOLOGIES LTD. · CLEARSTREAM TECHNOLOGIES, LTD. · CLEARSTREAM TECHNOLOGIES LTD · ClearStream Technologies

FDA 510(k) clearances by year

12008 · K072947

22009 · K093139

32010 · K102035

12011 · K112335

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access 1Catheter, Angioplasty, Peripheral, Transluminal 1Catheter, Percutaneous 1Introducer, Catheter 1Stent, Iliac 1Iliac Covered Stent, Arterial 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K112335	BANTAM CATHETER (280MM BALLOON LENGTHS)	2011-10-12
US	K102035	SLEEK OTW PTA CATHETERS	2010-12-01
US	K101361	REEFLEX PTA CATHETER	2010-08-04
BR	80689099015	BANTAM	Class II
BR	10033439121	Halo One	Class II
BR	10033439122	Halo One (Revestido)	Class II
CA	78796	SLEEK RAPID EXCHANGE PTA DILATATION CATHETERS	Class IV
CA	87859	SLEEK OTW PTA CATHETER	Class IV