DPI Inhaler
- Risk class
- Class IIa
- CND nomenclatures code
- R03010302
- Trade name
- CDM Haler 2 x ½ x 2.45
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 07898935580536
- Basic UDI
- 789893558inhaler2N
- Version date
- October 03, 2022
- Manufacturer last update
- August 26, 2022
- Active status
- No
- Manufacturer name
- EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.
- Country
- Brazil
- Country type
- NON_EU
- Address
- 640 Florent Deleu Porto Feliz
- fabricio@emphasys-industrial.com
- 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
- Portugal
- Market available
- Germany:2024-06-03~2029-06-04, Portugal:2024-06-03~2029-06-04
- Human tissues
- No
- Animal tissues
- No
AEROSOL PORTABLE INHALERS
Access comprehensive regulatory information for DPI Inhaler in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 07898935580536 and manufactured by EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA. in Brazil.
This page provides complete registration details including trade name ( CDM Haler 2 x ½ x 2.45 ), 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.