Pure Global

NuMED CP STENT™ - HSA Registration DE0509693

Access comprehensive regulatory information for NuMED CP STENT™ in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509693 and owned by NuMED, Inc. The device was registered on August 27, 2024.

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 D
DE0509693
NuMED CP STENT™
HSA Registration Number: DE0509693
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Indicated for implantation in the native and/or recurrent coarctation of the aorta on patients with the following clinical conditions: • Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT scan; • Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; • Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; • Stenosis diameter >20% of the adjacent vessel diameter.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0509693
Registration Date
August 27, 2024
Retention Due Date
August 26, 2025
Product Owner
Short Name
NuMED
Address
2880 Main Street, Hopkinton, New York 12965, UNITED STATES
Registrant
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Address
37 UBI CRESCENT, SINGAPORE 408586
Model Information
Model Name(s)
BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter BIB® (Balloon in Balloon) Stent Placement Catheter CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT MOUNTED CP STENT
Model Identifier(s)
BB003 BB006 BB009 BB010 BB011 BB012 BB013 BB014 BB015 BB016 BB017 BB018 BB019 BB020 BB021 BB022 BB023 BB024 BB025 BB026 BB027 BB028 BB029 BB030 BB031 BB032 BB033 BB034 BB035 BB036 BB037 BB038 BB039 BB040 BB041 BB042 BB051 BB052 BB053 BB054 BB055 BB056 BB057 BB058 BB059 BB060 BB061 BB062 BB063 BB064 BB065 BB066 BB067 BB068 BB069 BB070 BB071 BB072 BB073 BB074 BB075 BB076 BB077 CP10Z39 CP10Z45 CP10Z50 CP10Z55 CP10Z60 CP8Z16 CP8Z22 CP8Z28 CP8Z34 CP8Z39 CP8Z45 CP8Z50 CP8Z55 CP8Z60 MCP001 MCP002 MCP003 MCP004 MCP005 MCP006 MCP007 MCP008 MCP009 MCP010 MCP011 MCP012 MCP013 MCP014 MCP015 MCP016 MCP017 MCP018 MCP019 MCP020 MCP021 MCP022 MCP023 MCP024 MCP025 MCP026 MCP027 MCP028 MCP029 MCP030 MCP031 MCP032 MCP033 MCP034 MCP035 MCP036 MCP037 MCP038 MCP040 MCP041 MCP042 MCP044 MCP045 MCP046 MCP048 MCP049 MCP050 MCP052 MCP053 MCP054 MCP056 MCP057 MCP058 MCP059 MCP060 MCP061 MCP062 MCP063 MCP064 MCP065 MCP066 MCP067 MCP068 MCP069 MCP070 MCP071 MCP072 MCP073 MCP074 MCP075 MCP076 MCP077 MCP078 MCP079