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Singapore HSA registration DE0509026

Goodman FINESTREAM S Plus PTA Balloon Dilatation Catheter

Singapore flagSingapore·CLASS D·Goodman Co., Ltd.·Registered March 05, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509026
Registration Date
March 05, 2024
Retention Due Date
March 04, 2026
Product description
The device is intended for dilatation of stenotic vessels (arteries, veins, or shunts) during percutaneous transluminal angioplasty (PTA) or post-stenting dilatation. However, coronary vessels and intracranial cerebral vessels are excluded as stenotic vessels.
Product Owner
Name
Goodman Co., Ltd.
Short Name
Goodman Co., Ltd.
Address
5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008, JAPAN
Registrant
Name
NIPRO ASIA PTE LTD
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Name
NIPRO ASIA PTE LTD
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Model information
Model Name(s)
FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter FINESTREAM S Plus PTA Balloon Dilatation Catheter
Model Identifier(s)
FSP-404040 FSP-404080 FSP-504040 FSP-504080 FSP-604040 FSP-604080 FSP-704040 FSP-704080 FSP-804040 FSP-804080
About this record

Access comprehensive regulatory information for Goodman FINESTREAM S Plus 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 DE0509026 and owned by Goodman Co., Ltd.. The device was registered on March 05, 2024.

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.

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