BULKFLEX ELASTIK
- Risk class
- Class I
- CND nomenclatures code
- Q010699
- Trade name
- BULKFLEX ELASTIK 22 GRANDE EL1 – BF42
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 07798148623450
- Basic UDI
- 779814862ELASST
- Version date
- June 07, 2024
- Manufacturer last update
- October 10, 2022
- Active status
- No
- Manufacturer name
- NUXEN SRL
- Country
- Argentina
- Country type
- NON_EU
- Address
- 2381 SITIO DE MONTEVIDEO LANUS
- info@deflex.com.ar
- SRN
- PT-AR-000002813
- Country
- Portugal
- Address
- Nº 4 Avenida Defensores de Chaves, Escritório Idea Spaces Lisboa
- cinterqualportugal@sapo.pt
- Telephone
- +351215838500
- Competent authority
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Spain
- Human tissues
- No
- Animal tissues
- No
MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
Access comprehensive regulatory information for BULKFLEX ELASTIK 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 07798148623450 and manufactured by NUXEN SRL in Argentina.
This page provides complete registration details including trade name (BULKFLEX ELASTIK 22 GRANDE EL1 – BF42), manufacturer information, authorized representative details, competent authority (INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), 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.