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Brosmed Apollo Balloon Dilatation Catheter - HSA Registration DE0019220

Access comprehensive regulatory information for Brosmed Apollo Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0019220 and owned by BrosMed Medical Co., Ltd.. The device was registered on April 28, 2017.

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.

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CLASS D
DE0019220
Brosmed Apollo Balloon Dilatation Catheter
HSA Registration Number: DE0019220
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Product Description

Indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only)

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0019220
Registration Date
April 28, 2017
Change Notification Approval Date
September 12, 2024
Retention Due Date
April 27, 2026
Product Owner
Short Name
BrosMed Medical Co., Ltd.
Address
15th building SMEs Venture Park, Songshan Lake Hi-Tech Zone, Dongguan City Guangdong, 523808, CHINA
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)
Apollo Balloon Dilatation Catheter 2.0 x 8mm Apollo Balloon Dilatation Catheter 2.0 x 10mm Apollo Balloon Dilatation Catheter 2.0 x 12mm Apollo Balloon Dilatation Catheter 2.0 x 15mm Apollo Balloon Dilatation Catheter 2.0 x 18mm Apollo Balloon Dilatation Catheter 2.25 x 8mm Apollo Balloon Dilatation Catheter 2.25 x 10mm Apollo Balloon Dilatation Catheter 2.25 x 12mm Apollo Balloon Dilatation Catheter 2.25 x 15mm Apollo Balloon Dilatation Catheter 2.25 x 18mm Apollo Balloon Dilatation Catheter 2.5 x 8mm Apollo Balloon Dilatation Catheter 2.5 x 10mm Apollo Balloon Dilatation Catheter 2.5 x 12mm Apollo Balloon Dilatation Catheter 2.5 x 15mm Apollo Balloon Dilatation Catheter 2.5 x 18mm Apollo Balloon Dilatation Catheter 2.75 x 8mm Apollo Balloon Dilatation Catheter 2.75 x 10mm Apollo Balloon Dilatation Catheter 2.75 x 12mm Apollo Balloon Dilatation Catheter 2.75 x 15mm Apollo Balloon Dilatation Catheter 2.75 x 18mm Apollo Balloon Dilatation Catheter 3.0 x 8mm Apollo Balloon Dilatation Catheter 3.0 x 10mm Apollo Balloon Dilatation Catheter 3.0 x 12mm Apollo Balloon Dilatation Catheter 3.0 x 15mm Apollo Balloon Dilatation Catheter 3.0 x 18mm Apollo Balloon Dilatation Catheter 3.25 x 8mm Apollo Balloon Dilatation Catheter 3.25 x 10mm Apollo Balloon Dilatation Catheter 3.25 x 12mm Apollo Balloon Dilatation Catheter 3.25 x 15mm Apollo Balloon Dilatation Catheter 3.25 x 18mm Apollo Balloon Dilatation Catheter 3.5 x 8mm Apollo Balloon Dilatation Catheter 3.5 x 10mm Apollo Balloon Dilatation Catheter 3.5 x 12mm Apollo Balloon Dilatation Catheter 3.5 x 15mm Apollo Balloon Dilatation Catheter 3.5 x 18mm Apollo Balloon Dilatation Catheter 3.75 x 8mm Apollo Balloon Dilatation Catheter 3.75 x 10mm Apollo Balloon Dilatation Catheter 3.75 x 12mm Apollo Balloon Dilatation Catheter 3.75 x 15mm Apollo Balloon Dilatation Catheter 3.75 x 18mm Apollo Balloon Dilatation Catheter 4.0 x 8mm Apollo Balloon Dilatation Catheter 4.0 x 10mm Apollo Balloon Dilatation Catheter 4.0 x 12mm Apollo Balloon Dilatation Catheter 4.0 x 15mm Apollo Balloon Dilatation Catheter 4.0 x 18mm Apollo Balloon Dilatation Catheter 4.5 x 8mm Apollo Balloon Dilatation Catheter 4.5 x 10mm Apollo Balloon Dilatation Catheter 4.5 x 12mm Apollo Balloon Dilatation Catheter 4.5 x 15mm Apollo Balloon Dilatation Catheter 4.5 x 18mm Apollo Balloon Dilatation Catheter 5.0 x 8mm Apollo Balloon Dilatation Catheter 5.0 x 10mm Apollo Balloon Dilatation Catheter 5.0 x 12mm Apollo Balloon Dilatation Catheter 5.0 x 15mm Apollo Balloon Dilatation Catheter 5.0 x 18mm
Model Identifier(s)
802-2008 802-2010 802-2012 802-2015 802-2018 802-2208 802-2210 802-2212 802-2215 802-2218 802-2508 802-2510 802-2512 802-2515 802-2518 802-2708 802-2710 802-2712 802-2715 802-2718 802-3008 802-3010 802-3012 802-3015 802-3018 802-3208 802-3210 802-3212 802-3215 802-3218 802-3508 802-3510 802-3512 802-3515 802-3518 802-3708 802-3710 802-3712 802-3715 802-3718 802-4008 802-4010 802-4012 802-4015 802-4018 802-4508 802-4510 802-4512 802-4515 802-4518 802-5008 802-5010 802-5012 802-5015 802-5018