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HSA · registration DE0509001

Goodman Powered3 NC Coronary Dilatation Catheter

SingaporeCardiovascularClass DGoodman Co., Ltd.
Verified
Official record identity
Registration number
DE0509001
Model name
Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter; Powered3 NC Coronary Dilatation Catheter
Model identifier
P3N25008; P3N25010; P3N25012; P3N25015; P3N27508; P3N27510; P3N27512; P3N27515; P3N30008; P3N30010; P3N30012; P3N30015; P3N32508; P3N32510; P3N32512; P3N32515; P3N35008; P3N35010; P3N35012; P3N35015; P3N37512; P3N40008; P3N40010; P3N40012; P3N40015; P3N45008
Registration date
February 28, 2024
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 product is used in percutaneous transluminal coronary angioplasty (PTCA) for the purpose of expanding stenotic lesions within an artery or for post inflation immediately following stenting.

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.