Bioglan AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000001889
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Bioglan AB makes
Bioglan AB manufactures Otospray and Otospray Junior, which are medical devices designed for otological applications. These products are formulated as topical sprays intended for ear canal treatment. The portfolio focuses on semi-solid and liquid formulations tailored for ear health interventions.
The company’s devices fall under EU Medical Device Regulation Class I and are registered in the EU’s eudamed database. Bioglan AB is based in Sweden and adheres to regulatory requirements for Class I medical devices within the European Union.
Catalogue
Otospray Ref 001402
Regimes: CE MDR Registry: EUDAMEDOtospray Junior Ref 001401
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000001889
- EU VAT number
- SE556757211901
- EUDAMED status
- Active
- EUDAMED registered name
- Bioglan AB
- Registered address
- 31, Borrgatan, 21124, Malmö, Sweden
- Website
- www.bioglan.se
- [email protected]
- Phone
- +46 40 28 75 00
- PRRC contact
- Stefan Magnusson
From the company website
Pharmaceuticals within the field of semi-solids and liquids: Bioglan offer product development to full-scale manufacturing.
Frequently asked questions
How many devices does Bioglan AB have in the registry?
The registry currently lists 2 devices for Bioglan AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioglan AB's devices?
Among its 2 most recently registered devices, Bioglan AB has devices listed in EUDAMED (2 devices).
What risk classes do Bioglan AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bioglan AB's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bioglan AB in the registry?
The most recently registered devices listed for Bioglan AB include Otospray and Otospray Junior.