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Singapore HSA registration DE0505258

Vascular Solutions Teleflex MANTA™ Vascular Closure Device

Singapore flagSingapore·CLASS D·Vascular Solutions LLC·Registered December 18, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0505258
Registration Date
December 18, 2020
Change Notification Approval Date
April 22, 2025
Retention Due Date
December 17, 2025
Product description
The MANTA device is intended to be used following a large bore percutaneous procedure to close and seal the vascular puncture.The 14F MANTA Vascular Closure Device is for access sites in the femoral artery following the use of 10-14F devices or sheaths (maximum OD of 18F). The 18F MANTA Vascular Closure Device is for access sites in the femoral artery following the use of 15-20F devices or sheaths (maximum OD of 25F).The intended purpose of the Depth Locator and Sheath markings are to determine the depth in which the implant is to be deployed.
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)
Manta Depth Locator 14F Manta Depth Locator 8F MANTA™ Vascular Closure Device 18F  MANTA™ Vascular Closure Device 14F
Model Identifier(s)
114F 188F 2115NE 2156NE
About this record

Access comprehensive regulatory information for Vascular Solutions Teleflex MANTA™ Vascular Closure Device in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505258 and owned by Vascular Solutions LLC. The device was registered on December 18, 2020.

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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