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HSA · registration DE0508574

Goodman Aperta NSE Coronary Dilatation Catheter

SingaporeCardiovascularClass DGoodman Co., Ltd.
Verified
Official record identity
Registration number
DE0508574
Model name
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
APN20013; APN22513; APN25013; APN27513; APN30013; APN32513; APN35013; APN40013
Registration date
October 16, 2023
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
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Published parties
Product owner
Goodman Co., Ltd.
Registrant / registration holder
NIPRO ASIA PTE LTD
Official 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.

Additional source fields
Product owner address
5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008, Japan
Registrant address
6 TEMASEK BOULEVARD, #31-01/02, SUNTEC TOWER FOUR, Singapore 038986
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.