Angeion Medical Tri-Wedge PTA Scoring Balloon Dilatation Catheter - HSA Registration DE0504473
Access comprehensive regulatory information for Angeion Medical Tri-Wedge PTA Scoring 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 DE0504473 and owned by Angeion Medical International Pte Ltd. The device was registered on May 13, 2020.
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.
Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0504473
Angeion Medical Tri-Wedge PTA Scoring Balloon Dilatation Catheter
HSA Registration Number: DE0504473
Product Description
The balloon dilatation catheter is indicated to dilate stenoses in the femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504473
Registration Date
May 13, 2020
Change Notification Approval Date
July 16, 2020
Retention Due Date
May 12, 2025
Product Owner
Short Name
Angeion Medical International Pte Ltd
Address
114 LAVENDER STREET, CT HUB 2, #03-61, SINGAPORE 338729
Registrant
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Model Information
Model Name(s)
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x20mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x30mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x40mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x60mm, 90cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 3.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 4.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 5.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 6.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 7.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.018" 8.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x20mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x30mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x40mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x60mm, 75cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 3.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 4.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 5.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 6.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 7.0x60mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x20mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x30mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x40mm, 50cm
Tri-Wedge PTA Scoring Balloon Dilatation Catheter 0.035" 8.0x60mm, 50cm
Model Identifier(s)
21-18L32
21-18L33
21-18L34
21-18L36
21-18L42
21-18L43
21-18L44
21-18L46
21-18L52
21-18L53
21-18L54
21-18L56
21-18L62
21-18L63
21-18L64
21-18L66
21-18L72
21-18L73
21-18L74
21-18L76
21-18L82
21-18L83
21-18L84
21-18L86
21-18S32
21-18S33
21-18S34
21-18S36
21-18S42
21-18S43
21-18S44
21-18S46
21-18S52
21-18S53
21-18S54
21-18S56
21-18S62
21-18S63
21-18S64
21-18S66
21-18S72
21-18S73
21-18S74
21-18S76
21-18S82
21-18S83
21-18S84
21-18S86
21-35L32
21-35L33
21-35L34
21-35L36
21-35L42
21-35L43
21-35L44
21-35L46
21-35L52
21-35L53
21-35L54
21-35L56
21-35L62
21-35L63
21-35L64
21-35L66
21-35L72
21-35L73
21-35L74
21-35L76
21-35L82
21-35L83
21-35L84
21-35L86
21-35S32
21-35S33
21-35S34
21-35S36
21-35S42
21-35S43
21-35S44
21-35S46
21-35S52
21-35S53
21-35S54
21-35S56
21-35S62
21-35S63
21-35S64
21-35S66
21-35S72
21-35S73
21-35S74
21-35S76
21-35S82
21-35S83
21-35S84
21-35S86