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Goodman Aperta NSE Coronary Dilatation Catheter - HSA Registration DE0508574

Access comprehensive regulatory information for Goodman Aperta NSE Coronary 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 DE0508574 and owned by Goodman Co., Ltd.. The device was registered on October 16, 2023.

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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CLASS D
DE0508574
Goodman Aperta NSE Coronary Dilatation Catheter
HSA Registration Number: DE0508574
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Product Description

The purpose of the use of the product is to dilate atherosclerotic obstructed segments of coronary arteries that are difficult to dilate by regular POBA (plain old balloon angioplasty) to improve coronary artery flow.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508574
Registration Date
October 16, 2023
Retention Due Date
October 15, 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)
Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter Aperta NSE Coronary Dilatation Catheter
Model Identifier(s)
APN20013 APN22513 APN25013 APN27513 APN30013 APN32513 APN35013 APN40013