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STERILE INTRAGASTRIC BALLOON - EUDAMED Registration 07898258291089

Access comprehensive regulatory information for STERILE INTRAGASTRIC BALLOON 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 07898258291089 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 INTRAGASTRIC BALLOON), 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 IIb
07898258291089
No
STERILE INTRAGASTRIC BALLOON
Trade Name: STERILE INTRAGASTRIC BALLOON
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Device Description (EMDN)

INTRAGASTRIC BALLOON SYSTEMS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
G030601
Trade Name
STERILE INTRAGASTRIC BALLOON
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07898258291089
Basic UDI
B-07898258291089
Version Date
October 18, 2022
Manufacturer Last Update
July 25, 2022
Active Status
No
Manufacturer
Country
Brazil
Country Type
NON_EU
Address
1585 Av das Industrias Cachoeirinha
Email
vanessa.cardoso@medicone.com.br
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Portugal
Market Available
Portugal:2017-07-27~2024-05-27, Spain:2017-07-27~2024-05-27
Device Characteristics
Human Tissues
No
Animal Tissues
No