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DPI Inhaler - EUDAMED Registration 07898935580598

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 07898935580598 and manufactured by EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA. in Brazil.

This page provides complete registration details including trade name (CDA Haler 45 x 1.00 x 3.5 - C - V1 - R), manufacturer information, authorized representative details, competent authority (INFARMED - Autoridade Nacional do Medicamento e Produtos de Saรบde, 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.

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EUDAMED Official Data
Class IIa
07898935580598
No
DPI Inhaler
Trade Name: CDA Haler 45 x 1.00 x 3.5 - C - V1 - R
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Device Description (EMDN)

AEROSOL PORTABLE INHALERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
R03010302
Trade Name
CDA Haler 45 x 1.00 x 3.5 - C - V1 - R
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07898935580598
Basic UDI
789893558inhaler2N
Version Date
October 03, 2022
Manufacturer Last Update
August 26, 2022
Active Status
No
Manufacturer
Country
Brazil
Country Type
NON_EU
Address
640 Florent Deleu Porto Feliz
Email
fabricio@emphasys-industrial.com
Authorized Representative
SRN
PT-AR-000002813
Country
Portugal
Address
Nยบ 4 Avenida Defensores de Chaves, Escritรณrio Idea Spaces Lisboa
Email
cinterqualportugal@sapo.pt
Telephone
+351215838500
Regulatory Information
Competent Authority
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saรบde, 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
Device Characteristics
Human Tissues
No
Animal Tissues
No