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Singapore HSA registration DE0503972

Vascular Solution Guardian II hemostasis valve

Singapore flagSingapore·CLASS B·Vascular Solutions LLC·Registered December 27, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0503972
Registration Date
December 27, 2019
Retention Due Date
December 26, 2025
Product description
Guardian® hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian® hemostasis valves are indicated for maintaining a seal around diagnostic/ interventional devices with outside diameters up to 8F (0.105” or 2.67 mm) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vasculature. The sidearm extension tubing included is provided to extend the sidearm of the Guardian® II and Guardian® II NC Hemostasis Valves.
Product Owner
Name
Vascular Solutions LLC
Short Name
Vascular Solutions LLC
Address
6464 Sycamore Court North, Minneapolis, Minnesota, 55369, UNITED STATES
Registrant
Name
TELEFLEX MEDICAL ASIA PTE. LTD.
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
Name
TELEFLEX MEDICAL ASIA PTE. LTD.
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model information
Model Name(s)
Guardian® II Hemostasis Valve Guardian® II Hemostasis Valve Guardian® II Hemostasis Valve Guardian® II Hemostasis Valve Guardian® II NC Hemostasis Valve Guardian® II NC Hemostasis Valve Guardian® II NC Hemostasis Valve Guardian® II NC Hemostasis Valve
Model Identifier(s)
FH101 FH101-25 FH101-50 FH101-T FH102 FH102-25 FH102-50 FH102-T
About this record

Access comprehensive regulatory information for Vascular Solution Guardian II hemostasis valve in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503972 and owned by Vascular Solutions LLC. The device was registered on December 27, 2019.

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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