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Sign in to claim this brandG.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
US
Last updated May 23, 2026
What G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh makes
G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse produces ultraviolet sun tanning lamps designed for controlled exposure to simulate natural sunlight.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse manufacture?
G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse manufactures ultraviolet sun tanning lamps. These devices are designed to provide controlled exposure to ultraviolet light, simulating natural sunlight for cosmetic purposes.
Where is G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse based?
The company is based in the United States. This location is relevant for regulatory oversight and compliance with local and international medical device regulations.
How are the devices manufactured by G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse classified under FDA regulations?
The devices produced by G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse are classified as Class II devices under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness.
Which regulatory registries or pathways are used to list the devices manufactured by G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse?
The devices manufactured by G.I.E.- Gesellschaft für Lichttechnische Erzeugnisse are listed via the FDA’s 510(k) pathway. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (66)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Original Hanau | Strahler OH C 1000 ORB F | FDA UDI | Class II | Unknown |
| Original Hanau | Strahler OH M 600 EF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH C 400 EF | FDA UDI | Class II | Active |
| Megaline | Strahler BQ 460 SF | FDA UDI | Class II | Active |
| Original Hanau | Strahler Varius EF vst | FDA UDI | Class II | Active |
| Hni | Strahler HNI 468 S (BQ 468 z4) | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH M 50/100 EF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH M 800 TSF | FDA UDI | Class II | Unknown |
| Original Hanau | Strahler OH M 60/80 EF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH C 460 SF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH N 24/50 EF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH N 800 SF | FDA UDI | Class II | Active |
| Original Hanau | Strahler OH M 400 SF | FDA UDI | Class II | Active |
| Hni | Strahler BQ 1156 z4 | FDA UDI | Class II | Unknown |
| Original Hanau | Strahler OH Collagen 30/50 EC | FDA UDI | Class II | Active |
| Ultraviolet Sun Tanning Lamp | K151674 | FDA 510(k) | Class II | Active |
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