Singapore HSA registration DE0509382

MEDARTIS APTUS FOREARM System

Singapore·CLASS C·Medartis AG·Registered June 11, 2024

Device classification

Device Class: CLASS C
Medical Speciality Area: Orthopaedics

Registration information

Registration Number: DE0509382
Registration Date: June 11, 2024
Retention Due Date: June 10, 2025

Product description

APTUS Forearm system is intended for fractures and osteotomies of the bones of the radius shaft and ulna shaft of the forearm

Product Owner

Name: Medartis AG
Short Name: Medartis AG
Address: Hochbergerstrasse 60E, 4057 Basel, Basel, SWITZERLAND

Registrant

Name: GEN-Y (S) PTE. LTD.
Address: 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305

Importer

Name: GEN-Y (S) PTE. LTD.
Address: 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305

Model information

Model Name(s): 2.5/2.8 Drill Guide, TriLock PLUS 2.0-2.8 Depth Gauge 2.8 Drill Guide 2.5/2.8 Drill Sleeve, Self-Holding Twist Drill Ø2.35mm x 50mm, L101mm, AO Twist Drill Ø2.35mm x 50mm, L101mm, AO Twist Drill Ø2.9mm x 10mm, L61mm, AO Twist Drill Ø2.9mm x 10mm, L61mm, AO 2.8 Countersink for Cortical Screws, AO 2.8 Countersink for Cortical Screws, AO 2.8 Tap, L75mm, AO 2.8 TriLock Radius Shaft Pl 10 Hole,t3.4 2.8 TriLock Radius Shaft Pl 10 Hole,t3.4 Template for A-4857.01 2.8 TriLock Radius Shaft Pl 14 Hole,t3.4 2.8 TriLock Radius Shaft Pl 14 Hole,t3.4 Template for A-4857.02 2.8 TriLock Radius Shaft Pl 18 Hole,t3.4 2.8 TriLock Radius Shaft Pl 18 Hole,t3.4 Template for A-4857.03 2.8 TriLock Radius Shaft Pl 22 Hole,t3.4 2.8 TriLock Radius Shaft Pl 22 Hole,t3.4 Template for A-4857.04 2.8 TriLock Ulna Shaft Pl 10 Hole, t3.4 2.8 TriLock Ulna Shaft Pl 10 Hole, t3.4 Template for A-4857.11 2.8 TriLock Ulna Shaft Pl 14 Hole, t3.4 2.8 TriLock Ulna Shaft Pl 14 Hole, t3.4 Template for A-4857.12 2.8 TriLock Ulna Shaft Pl 18 Hole, t3.4 2.8 TriLock Ulna Shaft Pl 18 Hole, t3.4 Template for A-4857.13 2.8 TriLock Ulna Shaft Pl 22 Hole, t3.4 2.8 TriLock Ulna Shaft Pl 22 Hole, t3.4 Template for A-4857.14 1.6 K-Wire, Trocar, 150mm, 10/Pkg 1.6 K-Wire, Trocar, 150mm, 1/Pkg 1.6 K-Wire, Trocar, 150mm 1.6 K-Wire, Lancet, 150mm, 10/Pkg 1.6 K-Wire, Lancet, 150mm, 1/Pkg 1.6 K-Wire, Lancet, 150mm 1.6 K-Wire, 60mm, Olive 10mm, 1/Pkg 1.6 K-Wire, 60mm, Olive 10mm 2.8 Cortical Screw 08mm, HD7, 5/Pkg 2.8 Cortical Screw 08mm, HD7, 1/Pkg 2.8 Cortical Screw 08mm, HD7 2.8 Cortical Screw 10mm, HD7, 5/Pkg 2.8 Cortical Screw 10mm, HD7, 1/Pkg 2.8 Cortical Screw 10mm, HD7 2.8 Cortical Screw 12mm, HD7, 5/Pkg 2.8 Cortical Screw 12mm, HD7, 1/Pkg 2.8 Cortical Screw 12mm, HD7 2.8 Cortical Screw 14mm, HD7, 5/Pkg 2.8 Cortical Screw 14mm, HD7, 1/Pkg 2.8 Cortical Screw 14mm, HD7 2.8 Cortical Screw 16mm, HD7, 5/Pkg 2.8 Cortical Screw 16mm, HD7, 1/Pkg 2.8 Cortical Screw 16mm, HD7 2.8 Cortical Screw 18mm, HD7, 5/Pkg 2.8 Cortical Screw 18mm, HD7, 1/Pkg 2.8 Cortical Screw 18mm, HD7 2.8 Cortical Screw 20mm, HD7, 5/Pkg 2.8 Cortical Screw 20mm, HD7, 1/Pkg 2.8 Cortical Screw 20mm, HD7 2.8 Cortical Screw 22mm, HD7, 5/Pkg 2.8 Cortical Screw 22mm, HD7, 1/Pkg 2.8 Cortical Screw 22mm, HD7 2.8 Cortical Screw 24mm, HD7, 5/Pkg 2.8 Cortical Screw 24mm, HD7, 1/Pkg 2.8 Cortical Screw 24mm, HD7 2.8 TriLock Screw 08mm, HD7, 5/Pkg 2.8 TriLock Screw 08mm, HD7, 1/Pkg 2.8 TriLock Screw 08mm, HD7 2.8 TriLock Screw 10mm, HD7, 5/Pkg 2.8 TriLock Screw 10mm, HD7, 1/Pkg 2.8 TriLock Screw 10mm, HD7 2.8 TriLock Screw 12mm, HD7, 5/Pkg 2.8 TriLock Screw 12mm, HD7, 1/Pkg 2.8 TriLock Screw 12mm, HD7 2.8 TriLock Screw 14mm, HD7, 5/Pkg 2.8 TriLock Screw 14mm, HD7, 1/Pkg 2.8 TriLock Screw 14mm, HD7 2.8 TriLock Screw 16mm, HD7, 5/Pkg 2.8 TriLock Screw 16mm, HD7, 1/Pkg 2.8 TriLock Screw 16mm, HD7 2.8 TriLock Screw 18mm, HD7, 5/Pkg 2.8 TriLock Screw 18mm, HD7, 1/Pkg 2.8 TriLock Screw 18mm, HD7 2.8 TriLock Screw 20mm, HD7, 5/Pkg 2.8 TriLock Screw 20mm, HD7, 1/Pkg 2.8 TriLock Screw 20mm, HD7 2.8 TriLock Screw 22mm, HD7, 5/Pkg 2.8 TriLock Screw 22mm, HD7, 1/Pkg 2.8 TriLock Screw 22mm, HD7 2.8 TriLock Screw 24mm, HD7, 5/Pkg 2.8 TriLock Screw 24mm, HD7, 1/Pkg 2.8 TriLock Screw 24mm, HD7
Model Identifier(s): A-2026 A-2031 A-2820 A-2826 A-3832 A-3832S A-3834 A-3834S A-3835 A-3835S A-3839 A-4857.01 A-4857.01S A-4857.01TP A-4857.02 A-4857.02S A-4857.02TP A-4857.03 A-4857.03S A-4857.03TP A-4857.04 A-4857.04S A-4857.04TP A-4857.11 A-4857.11S A-4857.11TP A-4857.12 A-4857.12S A-4857.12TP A-4857.13 A-4857.13S A-4857.13TP A-4857.14 A-4857.14S A-4857.14TP A-5040.41 A-5040.41/1 A-5040.41/2S A-5042.41 A-5042.41/1 A-5042.41/2S A-5045.41/1 A-5045.41/2S A-5800.08 A-5800.08/1 A-5800.08/1S A-5800.10 A-5800.10/1 A-5800.10/1S A-5800.12 A-5800.12/1 A-5800.12/1S A-5800.14 A-5800.14/1 A-5800.14/1S A-5800.16 A-5800.16/1 A-5800.16/1S A-5800.18 A-5800.18/1 A-5800.18/1S A-5800.20 A-5800.20/1 A-5800.20/1S A-5800.22 A-5800.22/1 A-5800.22/1S A-5800.24 A-5800.24/1 A-5800.24/1S A-5850.08 A-5850.08/1 A-5850.08/1S A-5850.10 A-5850.10/1 A-5850.10/1S A-5850.12 A-5850.12/1 A-5850.12/1S A-5850.14 A-5850.14/1 A-5850.14/1S A-5850.16 A-5850.16/1 A-5850.16/1S A-5850.18 A-5850.18/1 A-5850.18/1S A-5850.20 A-5850.20/1 A-5850.20/1S A-5850.22 A-5850.22/1 A-5850.22/1S A-5850.24 A-5850.24/1 A-5850.24/1S

About this record

Access comprehensive regulatory information for MEDARTIS APTUS FOREARM System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509382 and owned by Medartis AG. The device was registered on June 11, 2024.

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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