EUDAMED registration B140052310YesRespiratory Effort Sensors
- Risk class
- Class I
- CND nomenclatures code
- Z12100580
- Trade name
- Double-Loop Effort Belt
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- B140052310
- Basic UDI
- ++B140EffortFU
- Version date
- February 05, 2025
- 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
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Market available
- France:None~None, Germany:None~None, Ireland:None~None, Italy:None~None, Spain:None~None
- Human tissues
- No
- Animal tissues
- No
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Access comprehensive regulatory information for Respiratory Effort Sensors in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI B140052310 and manufactured by BRAEBON Medical Corporation in Canada.
This page provides complete registration details including trade name (Double-Loop Effort Belt), 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.