Data / Medical devices / Germany / German Medical Engineering GMBH
German Medical Engineering GMBH: FDA-registered device maker in Erlangen Bavaria, Germany, 6 510(k) clearances
German Medical Engineering GMBH is registered with the FDA (registration 3011024620) in Erlangen Bavaria, Germany. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011024620
- Address
- Dreikoenigstr. 6-8, Erlangen Bavaria, Germany, 91054
- Owner or operator
- German Medical Engineering GmbH (10047245)
- Roles
- Manufacturer
- First device listed
- July 25, 2014
- Registered through
- 2026
- Brand names listed
- ExSys 308 System, FlexSys Green 532 module, FlexSys IR 1550 nm, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys Yellow 577 module, LinScan, LinScan System, TwinScan 808/755 Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2023 | K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | GEX | Substantially Equivalent | Gme German Medical Engineering GmbH | accessdata.fda.gov |
| March 5, 2021 | K203054 | FlexSys | GEX | Substantially Equivalent | Gme German Medical Engineering GmbH | accessdata.fda.gov |
| November 19, 2019 | K192269 | TwinScan 808/755 Laser System | GEX | Substantially Equivalent | Gme German Medical Engineering GmbH | accessdata.fda.gov |
| July 23, 2018 | K180518 | GME LinScan Lite 808 Laser System | GEX | Substantially Equivalent | Gme German Medical Engineering GmbH | accessdata.fda.gov |
| July 31, 2015 | K150752 | GME ExSys 308 | FTC | Substantially Equivalent | Gme (German Medical Engineering) GmbH | accessdata.fda.gov |
| July 15, 2014 | K141063 | LINSCAN 808, LINSCAN 980 | GEX | Substantially Equivalent | Gme (German Medical Engineering) GmbH | accessdata.fda.gov |
Compare with other makers
Updated March 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.