Dx365 GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000038389
- Devices
- 1
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Dx365 GmbH makes
Dx365 GmbH manufactures lateral flow analyzers, including the Igloo Reader Pro, designed for rapid diagnostic testing. These devices support point-of-care (POCT) applications, such as lateral flow tests (LFT), fluorescence lateral flow assays (FLA), and blood-based diagnostics. They are intended for use in settings like schools, elder care facilities, fitness environments, and veterinary settings to deliver quick results.
The company’s products fall under EU Class A medical devices and are registered in the EUDAMED database. The portfolio is regulated under EU Medical Device Regulations, and the manufacturer is based in Germany.
Catalogue
Igloo Reader Pro Ref R-DA
CE IVDR EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000038389
- EU VAT number
- DE360633166
- EUDAMED status
- Active
- EUDAMED registered name
- Dx365 GmbH
- EUDAMED abbreviated name
- Dx365
- Registered address
- 14, Hedwig-Porschütz-Strasse 14, 10557, Berlin, Germany
- Website
- dx365.world
- linkedin.com/company/dx365
- [email protected]
- Phone
- +49 157 30324653
- PRRC contact
- Alexander Taran
Frequently asked questions
How many devices does Dx365 GmbH have in the registry?
The registry currently lists 1 device for Dx365 GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dx365 GmbH's devices?
Among its 1 most recently registered device, Dx365 GmbH has devices listed in EUDAMED (1 device).
What risk classes do Dx365 GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Dx365 GmbH's devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Dx365 GmbH in the registry?
The most recently registered devices listed for Dx365 GmbH include Igloo Reader Pro.