08434048476787
Ortesis de Rodilla
PRIM, S.A.·Class I·EU EUDAMED·Trade name: AIRTEX RODILLERA FLEJES/CINCHAS MNo
Device classification
- Risk class
- Class I
- CND nomenclatures code
- Y061209
- Trade name
- AIRTEX RODILLERA FLEJES/CINCHAS M
- Implantable
- No
- Reusable
- No
- Measuring function
- No
Registration information
- Primary DI
- 08434048476787
- Basic UDI
- 843404825ORTESISRODILLASD
- Version date
- February 09, 2025
- Manufacturer last update
- May 20, 2021
- Active status
- No
Manufacturer
- Manufacturer name
- PRIM, S.A.
- Country
- Spain
- Country type
- EU_MEMBER_STATE
- Address
- 43 Avenida del Llano Castellano Madrid
- eudamed1@prim.es
Regulatory information
- Competent authority
- Agencia Española de Medicamentos y Productos Sanitarios
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Spain
Device characteristics
- Human tissues
- No
- Animal tissues
- No
Device description (EMDN)
KNEE ORTHOSES
About this record
Access comprehensive regulatory information for Ortesis de Rodilla 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 08434048476787 and manufactured by PRIM, S.A. in Spain.
This page provides complete registration details including trade name (AIRTEX RODILLERA FLEJES/CINCHAS M), manufacturer information, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), 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.