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Coloplast Biatain Silicone Non-Border Foam Dressing - HSA Registration DE0508463

Access comprehensive regulatory information for Coloplast Biatain Silicone Non-Border Foam Dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508463 and owned by Coloplast A/S. The device was registered on September 08, 2023.

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
DE0508463
Coloplast Biatain Silicone Non-Border Foam Dressing
HSA Registration Number: DE0508463
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Product Description

Biatain Silicone Non-Border is intended for moist wound healing and exudate management. Biatain Silicone Non-Border is indicated for a wide range of low- to highly exuding wounds in patients 40 kg and above. This includes acute wounds such as donor sites, post-operative wounds and traumatic wounds; and chronic wounds such as leg ulcers, pressure ulcers and noninfected diabetic foot ulcers.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508463
Registration Date
September 08, 2023
Retention Due Date
September 07, 2025
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
10 RAEBURN PARK, #01-33, SINGAPORE 088702 47 JALAN BUROH, #09-01, SINGAPORE 619491
Model Information
Model Name(s)
Biatain Silicone Non-Border Biatain Silicone Non-Border Biatain Silicone Non-Border Biatain Silicone Non-Border Biatain Silicone Non-Border
Model Identifier(s)
39022 39023 39024 39025 39026