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Stellartech Research Corp.

USA · Milpitas

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 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

10listed device types

Class I 0Class II 4Class III 6

plus 12 registration records and 11 510(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

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 1Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

pendingnot queried

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 States12 registration records, 11 510(k), 0 PMA

Manufacturer names merged into this page: Stellartech Research Corp.

FDA 510(k) clearances by year

12000

12001

12002

32003

32004

12005

12006

FDA listed device types

showing 8 of 10

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter 1Bronchial Thermoplasty System 1Cardiac Ablation Percutaneous Catheter 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation 1Ablation Catheter, Renal Denervation 1Electrosurgical, Cutting & Coagulation & Accessories 1System, Therapeutic, X-Ray 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061544	STELLARTECH 100 COAGULATION SYSTEM	2006-10-13
US	K050831	STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A	2005-04-12
US	K042909	STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A	2004-11-12

Stellartech Research Corp.

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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