Bioptron AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000041313 FEI 3003775404
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Bioptron AG makes
Bioptron AG manufactures light therapy systems, including the Bioptron PRO and Bioptron Compact III, designed for phototherapy applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Bioptron B2 Ref PAG-880
CE MDD EUDAMEDBIOPTRON MedAll Ref PAG-960
CE MDD EUDAMEDBIOPTRON Pro1 (BPro1) Ref PAG-990
CE MDD EUDAMED- 510(k) 510(k)
Company details
- EUDAMED SRN
- CH-MF-000041313
- FDA FEI number
- 3003775404
- EU VAT number
- CHE-106.274.648
- EUDAMED status
- Active
- EUDAMED registered name
- BIOPTRON AG
- Registered address
- 23, Sihleggstrasse, CH-8832, Wollerau, Switzerland
- Website
- www.bioptron.com
- [email protected]
- PRRC contact
- Michal Prazmo
Frequently asked questions
How many devices does BIOPTRON AG have in the registry?
The registry currently lists 4 devices for BIOPTRON AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOPTRON AG's devices?
Among its 4 most recently registered devices, BIOPTRON AG has devices listed in EUDAMED (3 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BIOPTRON AG's devices fall under?
Among its 4 most recently registered devices, the classes recorded for BIOPTRON AG's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BIOPTRON AG in the registry?
The most recently registered devices listed for BIOPTRON AG include BIOPTRON B2, BIOPTRON MedAll, BIOPTRON Pro1 (BPro1) and BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM.