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NuMED Tyshak II® Percutaneous Transluminal Valvuloplasty Catheter - HSA Registration DE0006007

Access comprehensive regulatory information for NuMED Tyshak II® 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 DE0006007 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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CLASS D
DE0006007
NuMED Tyshak II® Percutaneous Transluminal Valvuloplasty Catheter
HSA Registration Number: DE0006007
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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
DE0006007
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 2 cm PTV catheter 5mm x 2 cm PTV catheter 6mm x2 cm PTV catheter 7mm x2 cm PTV catheter 8mm x 2 cm PTV catheter 9mm x 3 cm PTV catheter 10mm x 3 cm PTV catheter 12mm x 3 cm PTV catheter 12mm x 4 cm PTV catheter 7mm x 3 cm PTV catheter 8mm x 3 cm PTV catheter 14mm x 3 cm PTV catheter 14mm x 4 cm PTV catheter 14mm x 5 cm PTV catheter 14mm x 6 cm PTV catheter 15mm x 3 cm PTV catheter 15mm x 4 cm PTV catheter 15mm x 5 cm PTV catheter 15mm x 6 cm PTV catheter 16mm x 3 cm PTV catheter 16mm x 4 cm PTV catheter 16mm x 5 cm PTV catheter 16mm x 6 cm PTV catheter 17mm x 3 cm PTV catheter 17mm x 4 cm PTV catheter 17mm x 5 cm PTV catheter 17mm x 6 cm PTV catheter 18mm x 3 cm PTV catheter 18mm x 4 cm PTV catheter 18mm x 5 cm PTV catheter 18mm x 6 cm PTV catheter 20mm x 3 cm PTV catheter 20mm x 4 cm PTV catheter 20mm x 5 cm PTV catheter 20mm x 6 cm PTV catheter 22mm x 3 cm PTV catheter 22mm x 4 cm PTV catheter 22mm x 5 cm PTV catheter 22mm x 6 cm PTV catheter 23mm x 3 cm PTV catheter 23mm x 4 cm PTV catheter 23mm x 5 cm PTV catheter 23mm x 6 cm PTV catheter 25mm x 3 cm PTV catheter 25mm x 4 cm PTV catheter 25mm x 5 cm PTV catheter 25mm x 6 cm PTV catheter 30mm x 3 cm PTV catheter 30mm x 4 cm PTV catheter 30mm x 5 cm PTV catheter 30mm x 6 cm PTV catheter 4mm x 10 cm PTV catheter 30mm x 10cm PTV catheter 20mm x 2 cm PTV catheter 16mm x 2 cm PTV catheter 4mm x 2 cm PTV catheter 5mm x 2 cm PTV catheter 6mm x 2 cm PTV catheter 7mm x 2 cm PTV catheter 8mm x 2 cm PTV catheter 9mm x 3 cm PTV catheter 10mm x 3 cm PTV catheter 7mm x 3 cm PTV catheter 8mm x 3 cm PTV catheter 22mm x 2 cm PTV catheter 11mm x 2 cm PTV catheter 10mm x 4 cm PTV catheter 11mm x 4 cm PTV catheter 10mm x 2 cm PTV catheter 12mm x 6 cm PTV catheter 9mm x 2 cm PTV catheter 12mm x 2 cm PTV catheter 10mm x 6 cm PTV catheter 12mm x 2 cm PTV catheter 11mm x 3 cm PTV catheter 14mm x 2 cm PTV catheter 5mm x 3 cm PTV catheter 6mm x 3 cm PTV catheter 8mm x 4 cm PTV catheter 8mm x 6 cm PTV catheter 10mm x 5 cm PTV catheter 8mm x 5 cm PTV catheter 12mm x 5 cm PTV catheter 13mm x 4 cm PTV catheter 13mm x 2 cm PTV catheter 13mm x 3 cm PTV catheter 13mm x 5 cm PTV catheter
Model Identifier(s)
PDC500 PDC501 PDC502 PDC503 PDC504 PDC505 PDC506 PDC507 PDC508 PDC509 PDC510 PDC511 PDC512 PDC513 PDC514 PDC515 PDC516 PDC517 PDC518 PDC519 PDC520 PDC521 PDC522 PDC523 PDC524 PDC525 PDC526 PDC527 PDC528 PDC529 PDC530 PDC531 PDC532 PDC533 PDC534 PDC535 PDC536 PDC537 PDC538 PDC539 PDC540 PDC541 PDC542 PDC543 PDC544 PDC545 PDC546 PDC547 PDC548 PDC549 PDC550 PDC551 PDC552 SN001 SN002 SN003 SN004 SN005 SN006 SN007 SN008 SN009 SN010 SN011 SN013 SN11290 SO001 SO002 SO003 SO004 SO007 SO008 SO009 SO014 SO017 SO018 SO020 SO021 SO029 SO030 SO031 SO032 SO033 SO034 SO035 SO036 SO069