Singapore HSA registration DE0501761

Teleflex Hi-Fi® Non-Absorbable Surgical Sutures

Singapore·CLASS C·Teleflex Medical·Registered June 19, 2018

Device classification

Device Class: CLASS C
Medical Speciality Area: Orthopaedics

Registration information

Registration Number: DE0501761
Registration Date: June 19, 2018
Change Notification Approval Date: February 17, 2022
Retention Due Date: June 18, 2025

Product description

Hi-Fi® Non-Absorbable Surgical Sutures are indicated for use in approximation and / or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Product Owner

Name: Teleflex Medical
Short Name: Teleflex Medical
Address: 3015 Carrington Mill Blvd., Morrisville,, NC, 27560, UNITED STATES

Registrant

Name: CONMED SINGAPORE PTE. LTD.
Address: 10 JALAN KILANG, BT Merah Enterprise Centre, #03-01, SINGAPORE 159410

Importer

Name: CONMED SINGAPORE PTE. LTD. EXACTECH PTE. LTD.
Address: 10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410 10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410

Model information

Model Name(s): Hi-Fi® White Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgicla Suture, meets USP except for oversized diameter, 1 x 40 Inches (100cm), 2, (metric 5) HC-5 1/2 Circle Taper, 25.9mm Hi-Fi® 1 White Braided and 1 White/Blue Co-braid UHMWPE Nonabsorbable Surgical Suture, meets USP except for for oversized diameter, 2 x 40 Inches (100cm), 2, (metric 5) HC-5 1/2 Circle Taper, 25.9mm Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2, (metric 5) Hi-Fi® White Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2, (metric 5) Hi-Fi® Green/White Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2, (metric 5) Hi-Fi® White/Black Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2, (metric 5) Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 5, metric 7 HSCX48 Conventional Cutting, 48.0mm Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 5, (metric 7) Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 0, (metric 3.5) C-4 1/2 Circle Taper, 22.2mm Hi-Fi® White/Black Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 0, (metric 3.5) Hi-Fi® White Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 0, (metric 3.5) Hi-Fi® White/Green Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 0, (metric 3.5) Hi-Fi® White/Blue Co-braind - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 0, metric 3.5 HRT22 1/2 Circle, Diamond Point, 22.2mm Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2-0, (metric 3) HR22 1/2 Circle Taper, 19.8mm Hi-Fi® White/Blue Co-braid - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 36 Inches (90cm), 2-0, (metric 3) HRT20 1/2 Circle Diamond Point, 19.8mm Hi-Fi® Blue Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 40 inches (100cm), 2, (metric 5) Hi-Fi® Blue Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 40 Inches (100cm), 2, (metric 5), HC-5, 1/2 Circle, Taper, 25.9mm Hi-Fi® Blue Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except oversized diameter, 1 x 40 Inches (100cm), 2, (metric 5), HS26, 1/2 Circle, Reverse Cutting, 26.2mm Hi-Fi® Blue Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 40 Inches (100cm), 2, (metric 5), HS40, 1/2 Circle, Reverse Cutting, 40.1mm Hi-Fi® Blue Braided - Ultra High Molecular Weight Polyethylene Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 1 x 40 Inches (100cm), 2, (metric 5) HC-5 1/2 Circle, Taper, 25.9mm Hi-Fi® 1 Blue Braided and 1 White/Black Co-braid - UHMWPE Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 2 x 40 Inches (100cm), 2, (metric 5) Hi-Fi® 1 Blue Braided and 1 White/Black Co-braid - UHMWPE Nonabsorbable Surgical Suture, meets USP except for oversized diameter, 2, (metric 5), HC-5, 1/2 Circle, Taper, 25.9mm
Model Identifier(s): H5000 H5100 H5120 H5130 H5140 H5150 H5200 H5250 H5300 H5301 H5302 H5303 H5400 H5500 H5600 H6100 H6110T H6120RC H6140RC H6150T2 H6200 H6210T

About this record

Access comprehensive regulatory information for Teleflex Hi-Fi® Non-Absorbable Surgical Sutures in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501761 and owned by Teleflex Medical. The device was registered on June 19, 2018.

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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