Singapore HSA registration DE0507114
GME FlexSys
Singapore·CLASS B·GME German Medical Engineering GmbH·Registered July 27, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0507114
- Registration Date
- July 27, 2022
- Retention Due Date
- July 26, 2025
Product description
The intended use of the device FlexSys with UVB EPL 308 or UVB LED 308 modules is: - Psoriasis - Hypo-pigmentation, Vitiligo - Atopic dermatitis, atopic eczema - Alopecia areata - Mycosis fungoides - Lichen planus
Product Owner
- Short Name
- GME German Medical Engineering GmbH
- Address
- Dreikoenigstr. 6-8 91054 Erlangen, GERMANY
Registrant
- Address
- 140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Importer
- Address
- 140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Model information
- Model Name(s)
- Flexsys Exsys 308 UVB LED 308
- Model Identifier(s)
- 1070 1071 1072
About this record
Access comprehensive regulatory information for GME FlexSys in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507114 and owned by GME German Medical Engineering GmbH. The device was registered on July 27, 2022.
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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