Singapore HSA registration DE0508651
Molnlycke Biogel M
Singapore·CLASS B·Molnlycke Health Care AB·Registered November 08, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508651
- Registration Date
- November 08, 2023
- Change Notification Approval Date
- September 16, 2024
- Retention Due Date
- November 07, 2025
Product description
Intended for single-use to cover the hands and wrists for transient and short term invasive use both surgically and with respect to body orifices. Act as a barrier to cross-infection, thereby reducing the risk of infection. A powder-free sterile surgical glove is a disposable device that is intended to be worn by healthcare professionals on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product Owner
- Short Name
- Molnlycke Health Care AB
- Address
- Gamlestadsvägen 3C, Box 130 80, SE-402 52, Göteborg, SWEDEN, SWEDEN
Registrant
- Address
- 298 TIONG BAHRU ROAD, CENTRAL PLAZA, #07-03, SINGAPORE 168730
Importer
- Address
- 298 TIONG BAHRU ROAD, CENTRAL PLAZA, #07-03, SINGAPORE 168730
Model information
- Model Name(s)
- Biogel M Biogel M Biogel M Biogel M Biogel M Biogel M Biogel M Biogel M
- Model Identifier(s)
- 82355 82360 82365 82370 82375 82380 82385 82390
About this record
Access comprehensive regulatory information for Molnlycke Biogel M in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508651 and owned by Molnlycke Health Care AB. The device was registered on November 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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