Pure Global
08434048476800

Ortesis de Rodilla

PRIM, S.A.·Class I·EU EUDAMED·Trade name: AIRTEX RODILLERA FLEJES/CINCHAS XL No
Device classification
Risk class
Class I
CND nomenclatures code
Y061209
Trade name
AIRTEX RODILLERA FLEJES/CINCHAS XL
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08434048476800
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
Email
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 08434048476800 and manufactured by PRIM, S.A. in Spain.

This page provides complete registration details including trade name (AIRTEX RODILLERA FLEJES/CINCHAS XL ), 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.