Pure Global

Goodman NSE PTA Balloon Dilatation Catheter - HSA Registration DE0507396

Access comprehensive regulatory information for Goodman NSE PTA Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507396 and owned by Goodman Co., Ltd.. The device was registered on October 21, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0507396
Goodman NSE PTA Balloon Dilatation Catheter
HSA Registration Number: DE0507396
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

This device is used for percutaneous transluminal angioplasty (PTA) to dilate a stenotic lesion in peripheral arteries and stenotic lesions of arteriovenous dialysis fistula, whereby it is considered that dilatation of a conventional balloon would result in inadequate lesion expansion. This device is not for use in the coronary and intracranial vessels including carotid arteries.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0507396
Registration Date
October 21, 2022
Retention Due Date
October 20, 2025
Product Owner
Short Name
Goodman Co., Ltd.
Address
5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008, JAPAN
Registrant
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Model Information
Model Name(s)
NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter NSE PTA Balloon Dilatation Catheter
Model Identifier(s)
NW18-05040020 NW18-05040040 NW18-05050020 NW18-05050040 NW18-05060020 NW18-05060040 NW18-09040040 NW18-09050040 NW18-09060040 NW18-09070040 NW18-14540040 NW18-14550040 NW18-14560040 NW18-14570040