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Molnlycke Biogel M - HSA Registration DE0508651

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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CLASS B
DE0508651
Molnlycke Biogel M
HSA Registration Number: DE0508651
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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.

Device 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 Owner
Short Name
Molnlycke Health Care AB
Address
Gamlestadsvรคgen 3C, Box 130 80, SE-402 52, Gรถteborg, 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