Singapore HSA registration DE0510606

Goodman Aperta NSE PTA Balloon Dilatation Catheter

Singapore·CLASS B·Goodman Co., Ltd.·Registered April 17, 2025

Device classification

Device Class: CLASS B
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0510606
Registration Date: April 17, 2025
Retention Due Date: April 16, 2026

Product description

This product is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This product is not for use in the coronary or neuro-vasculature including carotid arteries.

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): Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter Aperta NSE PTA Balloon Dilatation Catheter
Model Identifier(s): AA18-05040040 AA18-05050040 AA18-05060040 AA18-05070040 AA18-05080040 AA18-09040040 AA18-09050040 AA18-09060040 AA18-09070040 AA18-09080040 AW18-05040040 AW18-05050040 AW18-05060040 AW18-05070040 AW18-05080040 AW18-09040040 AW18-09050040 AW18-09060040 AW18-09070040 AW18-09080040 AW18-14540040 AW18-14550040 AW18-14560040 AW18-14570040 AW18-14580040

About this record

Access comprehensive regulatory information for Goodman Aperta NSE PTA Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510606 and owned by Goodman Co., Ltd.. The device was registered on April 17, 2025.

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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