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NuMED Tyshak® Percutaneous Transluminal Valvuloplasty Catheter - HSA Registration DE0006008

Access comprehensive regulatory information for NuMED Tyshak® Percutaneous Transluminal Valvuloplasty 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 DE0006008 and owned by NuMED, Inc. The device was registered on February 18, 2011.

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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HSA Official Data
CLASS D
DE0006008
NuMED Tyshak® Percutaneous Transluminal Valvuloplasty Catheter
HSA Registration Number: DE0006008
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Product Description

Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis. - A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0006008
Registration Date
February 18, 2011
Change Notification Approval Date
April 30, 2024
Retention Due Date
February 17, 2026
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)
4mm x 1 cm PTV catheter 5mm x 1 cm PTV catheter 5mm x 2 cm PTV catheter 6mm x 1 cm PTV catheter 6mm x 2 cm PTV catheter 7mm x 1.5 cm PTV catheter 8mm x 1.5 cm PTV catheter 8mm x 3 cm PTV catheter 9mm x 2 cm PTV catheter 10mm x 2 cm PTV catheter 10mm x 3 cm PTV catheter 10mm x 4 cm PTV catheter 12mm x 2.5 cm PTV catheter 12mm x 3 cm PTV catheter 12mm x 4 cm PTV catheter 15mm x 3 cm PTV catheter 18mm x 3 cm PTV catheter 20mm x 4 cm PTV catheter 22mm x 4 cm PTV catheter 25mm x 4 cm PTV catheter 4mm x 2 cm PTV catheter 5mm x 3cm PTV catheter 6mm x 3 cm PTV catheter 7mm x 3 cm PTV catheter 8mm x 3 cm PTV catheter 9mm x 3 cm PTV catheter 18mm x 6 cm PTV catheter 20mm x 6 cm PTV catheter 5mm x 2 cm PTV catheter 6mm x 2 cm PTV catheter 8mm x 3cm PTV catheter 12mm x 2 cm PTV catheter 15mm x 2 cm PTV catheter 18mm x 2cm PTV catheter 5mm x 4 cm PTV catheter 6mm x 4 cm PTV catheter 7mm x 4 cm PTV catheter 8mm x 4 cm PTV catheter 12mm x 5 cm PTV catheter 15mm x 5 cm PTV catheter 18mm x 5 cm PTV catheter 20mm x 3 cm PTV catheter 10mm x 4 cm PTV catheter 8mm x 2cm PTV catheter 15mm x 4 cm PTV catheter 10mm x 5 cm PTV catheter 20mm x 5 cm PTV catheter 5mm x 4 cm PTV catheter 6mm x 6 cm PTV catheter 8mm x 4 cm PTV catheter 8mm x 6 cm PTV catheter 10mm x 4 cm PTV catheter 10mm x 6 cm PTV catheter 10mm x 6 cm PTV catheter 12mm x 6 cm PTV catheter 12mm x 7 cm PTV catheter 15mm x 6 cm PTV catheter 18mm x 10 cm PTV catheter 20mm x 10 cm PTV catheter 6mm x 2 cm PTV catheter 6mm x 2 cm PTV catheter 8mm x 2 cm PTV catheter 10mm x 2 cm PTV catheter 22mm x 3 cm PTV catheter 8mm x 4 cm PTV catheter 8mm x 6 cm PTV catheter 8mm x 8 cm PTV catheter 15mm x 10 cm PTV catheter 25mm x 6 cm PTV catheter 5mm x 2 cm PTV catheter 10mm x 8 cm PTV catheter 10mm x 10 cm PTV catheter 18mm x 4 cm PTV catheter 25mm x 5 cm PTV catheter 10mm x 3 cm PTV catheter 10mm x 3 cm PTV catheter 25mm x 5.5 cm PTV catheter 22mm x 5.5 cm PTV catheter 22mm x 5cm PTV catheter 20mm x 5.5 cm PTV catheter 9mm x 4 cm PTV catheter 6mm x 4 cm PTV catheter 6mm x 2 cm PTV catheter 10mm x 5 cm PTV catheter 10mm x 10 cm PTV catheter 12mm x 8 cm PTV catheter 15mm x 8 cm PTV catheter 18mm x 8 cm PTV catheter 18mm x 2 cm PTV catheter 15mm x 2 cm PTV catheter 18mm x 4 cm PTV catheter 13mm x 5 cm PTV catheter 19mm x 9 cm PTV catheter 20mm x 9 cm PTV catheter 6mm x 5 cm PTV catheter 6mm x 8 cm PTV catheter 20mm x 8 cm PTV catheter 22mm x 5.5 cm PTV catheter 7mm x 2 cm PTV catheter 9mm x 2 cm PTV catheter 10mm x 2 cm PTV catheter 8mm x 3 cm PTV catheter 9mm x 3 cm PTV catheter 10mm x 3 cm PTV catheter 7mm x 3 cm PTV catheter 23mm x 5.5 cm PTV catheter 15mm x 7 cm PTV catheter 18mm x 4 cm PTV catheter 7mm x 2 cm PTV catheter 7mm x 2 cm PTV catheter 8mm x 2 cm PTV catheter 15mm x 4 cm PTV catheter 10mm x 8 cm PTV catheter 10mm x 3 cm PTV catheter 22mm x 6 cm PTV catheter 10mm x 5 cm PTV catheter 12mm x 3 cm PTV catheter 12mm x 4 cm PTV catheter 4mm x 2 cm PTV catheter 22mm x 6 cm PTV catheter 4mm x 3 cm PTV catheter 18mm x 5.5 cm PTV catheter 20mm x 5.5 cm PTV catheter 16mm x 6 cm PTV catheter 10mm x 8 cm PTV catheter 8mm x 8 cm PTV catheter 12mm x 2 cm PTV catheter 12mm x 3 cm PTV catheter 11mm x 3 cm PTV catheter 17mm x 6 cm PTV catheter 13mm x 4 cm PTV catheter 14mm x 5 cm PTV catheter 25mm x 4 cm PTV catheter 9mm x 2 cm PTV catheter 6mm x 3 cm PTV catheter 7mm x 3 cm PTV catheter 13mm x 6 cm PTV catheter 11mm x 3 cm PTV catheter 2 mm x 1 cm PTV catheter 10mm x 3 cm PTV catheter 10mm x 3 cm PTV catheter 12mm x 2.5 cm PTV catheter 12mm x 2 cm PTV catheter 12mm x 2 cm PTV catheter 12mm x 3.5 cm PTV catheter 12mm x 3 cm PTV catheter 12mm x 3cm PTV catheter 12mm x 4 cm PTV catheter 4mm x 2 cm PTV catheter 6mm x 1.5 cm PTV catheter 6mm x 2 cm PTV catheter 7mm x 2 cm PTV catheter 7mm x 2 cm PTV catheter 8mm x 2 cm PTV catheter 8mm x 3 cm PTV catheter 8mm x 4 cm PTV catheter 9mm x 3 cm PTV catheter 10mm x 2 cm PTV catheter 10mm x 4 cm PTV catheter 10mm x 6 cm PTV catheter 12mm x 2.5 cm PTV catheter 12mm x 2.5 cm PTV catheter 12mm x 2 cm PTV catheter 12mm x 3.5 cm PTV catheter 12mm x 3 cm PTV catheter 14mm x 3.5 cm PTV catheter 14mm x 3 cm PTV catheter 14mm x 4 cm PTV catheter 14mm x 4 cm PTV catheter 14mm x 6 cm PTV catheter 16mm x 3.5cm PTV catheter 16mm x 3 cm PTV catheter 16mm x 4 cm PTV catheter 16mm x 6 cm PTV catheter 20mm x 4 cm PTV catheter 20mm x 6 cm PTV catheter 22mm x 6 cm PTV catheter 25mm x 6 cm PTV catheter 6mm x 3 cm PTV catheter 9mm x 2 cm PTV catheter 13mm x 3 cm PTV catheter 8mm x 5 cm PTV catheter 12mm x 10 cm PTV catheter
Model Identifier(s)
PDC001 PDC002 PDC003 PDC004 PDC005 PDC006 PDC007 PDC008 PDC009 PDC010 PDC011 PDC012 PDC013 PDC014 PDC015 PDC016 PDC017 PDC018 PDC019 PDC020 PDC021 PDC022 PDC023 PDC024 PDC025 PDC026 PDC027 PDC028 PDC029 PDC030 PDC031 PDC032 PDC033 PDC034 PDC035 PDC036 PDC037 PDC038 PDC039 PDC040 PDC041 PDC042 PDC044 PDC045 PDC046 PDC047 PDC048 PDC049 PDC050 PDC051 PDC052 PDC053 PDC054 PDC055 PDC056 PDC057 PDC058 PDC059 PDC060 PDC061 PDC062 PDC063 PDC064 PDC065 PDC067 PDC068 PDC069 PDC070 PDC072 PDC073 PDC074 PDC075 PDC076 PDC077 PDC080 PDC081 PDC082 PDC083 PDC084 PDC085 PDC086 PDC087 PDC088 PDC089 PDC090 PDC091 PDC092 PDC093 PDC094 PDC095 PDC097 PDC098 PDC099 PDC100 PDC102 PDC103 PDC104 PDC108 PDC109 PDC113 PDC114 PDC115 PDC116 PDC117 PDC118 PDC120 PDC121 PDC122 PDC124 PDC126 PDC127 PDC128 PDC129 PDC130 PDC131 PDC132 PDC133 PDC134 PDC138 PDC139 PDC141 PDC142 PDC143 PDC144 PDC146 PDC147 PDC148 PDC149 PDC150 PDC151 PDC152 PDC153 PDC154 PDC155 PDC156 PDC157 PDC158 PDC159 PDC162 PDC163 PDC164 PDC165 PDC166 PDC167 PDC168 PDC169 PDC170 PDC171 PDC172 PDC173 PDC174 PDC175 PDC176 PDC177 PDC178 PDC179 PDC180 PDC181 PDC182 PDC183 PDC184 PDC185 PDC186 PDC187 PDC188 PDC189 PDC190 PDC191 PDC192 PDC193 PDC194 PDC195 PDC196 PDC197 PDC198 PDC199 PDC200 PDC201 PDC202 SN012 SO010 SO011 SO015