Singapore HSA registration DE0018253

Goodman LAXA LACROSSE PTCA Balloon Catheter

Singapore·CLASS D·Goodman Co., Ltd.·Registered June 16, 2016

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0018253
Registration Date: June 16, 2016
Change Notification Approval Date: April 21, 2022
Retention Due Date: June 15, 2025

Product description

The product is used in percutaneous transluminal coronary angioplasty (PTCA) for the purpose of dilating stenotic lesions within the coronary artery.

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, JAPAN

Registrant

Name: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address: 36 JALAN TUKANG, SINGAPORE 619266

Importer

Name: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address: 36 JALAN TUKANG, SINGAPORE 619266

Model information

Model Name(s): LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter LAXA LACROSSE PTCA Balloon Catheter
Model Identifier(s): LAX10005 LAX13010 LAX15012 LAX20010 LAX20012 LAX20015 LAX20020 LAX22512 LAX22515 LAX22520 LAX25010 LAX25012 LAX25015 LAX25020 LAX27512 LAX27515 LAX27520 LAX30012 LAX30015 LAX30020 LAX32515 LAX35012 LAX35015 LAX35020 LAX40015

About this record

Access comprehensive regulatory information for Goodman LAXA LACROSSE PTCA Balloon 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 DE0018253 and owned by Goodman Co., Ltd.. The device was registered on June 16, 2016.

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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