Singapore HSA registration DE0508463
Coloplast Biatain Silicone Non-Border Foam Dressing
Singapore·CLASS C·Coloplast A/S·Registered September 08, 2023Device 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 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.
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
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C