Biofrontera Pharma GmbH
Country not established FDA
Part of Biofrontera Pharma GmbH
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Biofrontera Pharma GmbH makes
Biofrontera Pharma GmbH manufactures skin photodynamic therapy lamps designed for medical use, including the BF-RhodoLED and RhodoLED® XL models. These devices emit specific wavelengths of light to activate photosensizers in targeted skin treatments, primarily for dermatological applications.
The company’s portfolio is classified under Class III medical devices in the US, requiring premarket approval. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The manufacturer is based in the United States.
Catalogue
- CE MDR GUDID
- GUDID
Company details
- DUNS number
- 332358501
- [email protected]
- Phone
- 781-245-1325
FDA establishments
- Biofrontera Pharma GmbH Leverkusen North Rhine-Westphalia · DE FEI 3011764519
Frequently asked questions
How many devices does Biofrontera Pharma GmbH have in the registry?
The registry currently lists 2 devices for Biofrontera Pharma GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biofrontera Pharma GmbH's devices?
Among its 2 most recently registered devices, Biofrontera Pharma GmbH has devices listed in FDA GUDID (2 devices).
What risk classes do Biofrontera Pharma GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biofrontera Pharma GmbH's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biofrontera Pharma GmbH in the registry?
The most recently registered devices listed for Biofrontera Pharma GmbH include BF-RhodoLED US and RhodoLED® XL US.
Which FDA establishments are linked to Biofrontera Pharma GmbH?
1 FDA establishment is linked to Biofrontera Pharma GmbH in the registry; they are listed on the company page.