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Coloplast Aris Trans-Obturator Surgical Kit - HSA Registration DE0504577

Access comprehensive regulatory information for Coloplast Aris Trans-Obturator Surgical Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504577 and owned by Coloplast A/S. The device was registered on June 09, 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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CLASS C
DE0504577
Coloplast Aris Trans-Obturator Surgical Kit
HSA Registration Number: DE0504577
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Product Description

Aris Introducers are surgical instruments intended to facilitate the correct placement of the Aris Transobturator Sling using a transobturator approach for the surgical treatment of female stress urinary incontinence

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0504577
Registration Date
June 09, 2020
Change Notification Approval Date
August 13, 2024
Retention Due Date
June 08, 2026
Product Owner
Short Name
Coloplast A/S
Address
Holtedam 1, 3050 Humlebaek, DENMARK
Registrant
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #15-18, SINGAPORE 079903
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
Aris Trans-Obturator Surgical Kit
Model Identifier(s)
UR3105