HSA · registration DE0508651Molnlycke Biogel M
- Registration number
- DE0508651
- Model name
- Biogel M; Biogel M; Biogel M; Biogel M; Biogel M; Biogel M; Biogel M; Biogel M
- Model identifier
- 82355; 82360; 82365; 82370; 82375; 82380; 82385; 82390
- Registration date
- November 08, 2023
- Source update date
- January 22, 2026
- Risk class
- Class B
- Product owner
- Molnlycke Health Care AB
- Registrant / registration holder
- MOLNLYCKE HEALTH CARE ASIA-PACIFIC PTE LTD
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 address
- Entreprenorsstraket 21, SE-431 53 Molndal, Sweden
- Registrant address
- 298 TIONG BAHRU ROAD, #07-03, CENTRAL PLAZA, Singapore 168730
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.