Singapore HSA registration DE0019247
Coloplast Biatain Silicone Foam Dressing
Singapore·CLASS C·Coloplast A/S·Registered May 16, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0019247
- Registration Date
- May 16, 2017
- Change Notification Approval Date
- February 20, 2024
- Retention Due Date
- May 15, 2026
Product description
Biatain Silicone is indicated for a wide range of low - to highly exuding wounds. Biatain Silicone Lite is indicated for a wide range of non - to low exuding wounds. This includes acute wounds such as donor sites, post operative wounds and traumatic wounds; and chronic wounds such as leg ulcers, pressure ulcers and non-infected diabetic foot ulcers. Biatain Silicone may be used to prevent post operative blistering.
Product Owner
- Name
- Coloplast A/S
- Short Name
- Coloplast A/S
- Address
- Holtedam 1, 3050 Humlebaek, DENMARK
Registrant
- Address
- 10 ANSON ROAD, INTERNATIONAL PLAZA, #15-18, SINGAPORE 079903
Importer
- Address
- 47 JALAN BUROH, #09-01, SINGAPORE 619491
Model information
- Model Name(s)
- Biatain Silicone Biatain Silicone Biatain Silicone Sacral Biatain Silicone Sacral Biatain Silicone Heel Biatain Silicone Multishape Biatain Silicone Biatain Silicone Biatain Silicone Biatain Silicone Biatain Silicone Biatain Silicone Lite Biatain Silicone Lite Biatain Silicone Lite Biatain Silcone Lite Biatain Silcone Lite
- Model Identifier(s)
- 33400 33401 33404 33405 33406 33408 33434 33435 33436 33437 33438 33444 33445 33446 33452 33453
About this record
Access comprehensive regulatory information for Coloplast Biatain Silicone 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 DE0019247 and owned by Coloplast A/S. The device was registered on May 16, 2017.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C