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GME German Medical Engineering GmbH

Germany·DE-MF-000009384

Last updated September 18, 2026

About

Transformyour skin FLEXSYS EVO The versatile laser platform that flexibly adapts to any clinical requirement while striking the right balance between effectiveness and safety – for the confidence you need and results you trust. Focus Indications: MED-UV Hand-held 308 nm excimer pulsed light device for the efficient treatment of a range of dermatological and aesthetic \[…\]

From the manufacturer's own website. Source

Information

Country
Germany
Address
23, Grimmstraße , Nürnberg, Germany
LinkedIn
—
Phone
+4991319341590
PRRC Contact
Dietmar Fischer
EUDAMED SRN
DE-MF-000009384
FDA FEI Number
—
DUNS Number
342234451

Catalogue (12)

DeviceModel / ReferenceRegistriesClassStatus
TwinScan 808/755 Laser System 1060
FDA UDI
Class IIActive
C + B Pelo 1042
FDA UDI
Class IIActive
Med-Uv Epl 308 1091
EUDAMED
Class IIbActive
Linscan 808, Linscan 980 K141063
FDA 510(k)
Class IIActive
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm K221623
FDA 510(k)
Class IIActive
TwinScan 808/755 Laser System K192269
FDA 510(k)
Class IIActive
GME ExSys 308 K150752
FDA 510(k)
Class IIActive
ExSys 1000
EUDAMEDFDA UDI
Class IIbActive
LinScan 1050
EUDAMEDFDA UDI
Class IIbActive
Med-Uv Epl 308 1091
EUDAMED
Class IIbActive
FlexSys 1070
EUDAMEDFDA UDI
Class IIbActive
LinScan 808 1040
EUDAMEDFDA 510(k)
Class IIbActive

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