EUDAMED registration B140MP80YesMediByte
- Risk class
- Class IIa
- CND nomenclatures code
- Z12100501
- Trade name
- MediByte
- Implantable
- No
- Reusable
- No
- Measuring function
- Yes
- Primary DI
- B140MP80
- Basic UDI
- B-B140MP80
- Version date
- March 20, 2024
- Manufacturer last update
- March 17, 2021
- Active status
- Yes
- Manufacturer name
- BRAEBON Medical Corporation
- Country
- Canada
- Country type
- NON_EU
- Address
- 100 Schneider Road Kanata
- info@braebon.com
- Name
- CEpartner4U
- SRN
- NL-AR-000000111
- Country
- Netherlands
- Address
- 13 Esdoornlaan Maarn
- office@cepartner4u.com
- Telephone
- +31343442524
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Germany
- Market available
- France:2006-01-01~None, Germany:2006-01-01~None, Italy:2006-01-01~None, Portugal:2006-01-01~None, Spain:2006-01-01~None
- Human tissues
- No
- Animal tissues
- No
POLYSOMNOGRAPHS
Access comprehensive regulatory information for MediByte in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI B140MP80 and manufactured by BRAEBON Medical Corporation in Canada.
This page provides complete registration details including trade name (MediByte), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.