HSA · registration DE0510606Goodman Aperta NSE PTA Balloon Dilatation Catheter
SingaporeGeneral HospitalClass BGoodman Co., Ltd.
Official record identity
- Registration number
- DE0510606
- Model name
- 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
- 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
- Registration date
- April 17, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Goodman Co., Ltd.
- Registrant / registration holder
- NIPRO ASIA PTE LTD
Official description
This product is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including 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.
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.