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Sign in to claim this brandBIOLUX TECHNOLOGY GMBH
Austria·AT-MF-000020789
Last updated September 17, 2026
What BIOLUX TECHNOLOGY GMBH makes
Biolux Technology GmbH manufactures pulsed electromagnetic therapy (PET) devices, including the OrthoPulse 2.0S, OrthoPulse 2.0E (OPi2E-100), OrthoPulse, and OrthoPulse Lite. These devices are designed for non-invasive bone and tissue stimulation, typically used in orthopedic and musculoskeletal applications to support healing processes.
The company’s portfolio includes devices classified as Class II and Class IIa under EU regulations, with listings in the EUDAMED registry and FDA’s 510(k) clearance database. The manufacturer is based in Austria.
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 Biolux Technology GmbH manufacture?
Biolux Technology GmbH specializes in pulsed electromagnetic therapy (PET) devices. These include models like the OrthoPulse 2.0S, OrthoPulse 2.0E (OPi2E-100), OrthoPulse, and OrthoPulse Lite. These devices are designed for non-invasive bone and tissue stimulation, primarily used in orthopedic and musculoskeletal applications to aid healing processes.
Where is Biolux Technology GmbH based?
Biolux Technology GmbH is headquartered in Austria. The company’s location is relevant for regulatory compliance and device distribution within the EU and other markets.
Which regulatory registries list Biolux Technology GmbH’s devices?
Biolux Technology GmbH’s devices are listed in the EUDAMED registry, which tracks EU medical devices, and the FDA’s 510(k) clearance database, which documents premarket notifications for devices seeking clearance in the United States. These listings reflect their regulatory status in those regions.
How are Biolux Technology GmbH’s devices classified under EU regulations?
Biolux Technology GmbH’s devices fall under Class II and Class IIa classifications in the EU. This classification is determined by risk assessment criteria, where Class IIa represents a moderate risk requiring specific conformity assessment procedures, while Class II covers higher-risk devices requiring additional scrutiny to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Austria
- Address
- 31, Neubaugasse, Absdorf, Austria
- Website
- www.orthopulse.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Daniela Penn
- EUDAMED SRN
- AT-MF-000020789
- FDA FEI Number
- 3017271131
- DUNS Number
- —
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OrthoPulse 2.0S | OPi2S-100 (P/N: 100-018) | EUDAMED | Class IIa | Active |
| OrthoPulse 2.0E (OPi2E-100) | K230905 | FDA 510(k) | Class II | Active |
| OrthoPulse® | OPi-CE101-BT | EUDAMED | Class IIa | Active |
| OrthoPulse® | OPi2E-100 | EUDAMED | Class IIa | Active |
| OrthoPulse Lite | OPiL-100 (P/N: 100-023) | EUDAMED | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biolux Technology GmbH US