HSA · registration DE0509026Goodman FINESTREAM S Plus PTA Balloon Dilatation Catheter
SingaporeCardiovascularClass DGoodman Co., Ltd.
Official record identity
- Registration number
- DE0509026
- Model name
- FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter; FINESTREAM S Plus PTA Balloon Dilatation Catheter
- Model identifier
- FSP-404040; FSP-404080; FSP-504040; FSP-504080; FSP-604040; FSP-604080; FSP-704040; FSP-704080; FSP-804040; FSP-804080
- Registration date
- March 05, 2024
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Goodman Co., Ltd.
- Registrant / registration holder
- NIPRO ASIA PTE LTD
Official description
The device is intended for dilatation of stenotic vessels (arteries, veins, or shunts) during percutaneous transluminal angioplasty (PTA) or post-stenting dilatation. However, coronary vessels and intracranial cerebral vessels are excluded as stenotic vessels.
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.