Sterile Penile Prosthesis
- Risk class
- Class IIb
- CND nomenclatures code
- P080202
- Trade name
- Sterile Penile Prostheses
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 07898258291812
- Basic UDI
- B-07898258291812
- Version date
- October 18, 2022
- Manufacturer last update
- July 25, 2022
- Active status
- No
- Manufacturer name
- Medicone Projetos e Solucoes para a Industria e a Saude Ltda.
- Country
- Brazil
- Country type
- NON_EU
- Address
- 1585 Av das Industrias Cachoeirinha
- vanessa.cardoso@medicone.com.br
- 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
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Portugal
- Market available
- Portugal:2017-07-27~2024-05-27
- Human tissues
- No
- Animal tissues
- No
PENILE PROSTHESES
Access comprehensive regulatory information for Sterile Penile Prosthesis in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 07898258291812 and manufactured by Medicone Projetos e Solucoes para a Industria e a Saude Ltda. in Brazil.
This page provides complete registration details including trade name (Sterile Penile Prostheses), 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.