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GME FlexSys - HSA Registration DE0507114

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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CLASS B
DE0507114
GME FlexSys
HSA Registration Number: DE0507114
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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

Device 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 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