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07798148623481

BULKFLEX ELASTIK

NUXEN SRL·Class I·EU EUDAMED·Trade name: BULKFLEX ELASTIK 22 PEQUEÑO EL3 – BF47No
Device classification
Risk class
Class I
CND nomenclatures code
Q010699
Trade name
BULKFLEX ELASTIK 22 PEQUEÑO EL3 – BF47
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
07798148623481
Basic UDI
779814862ELASST
Version date
June 07, 2024
Manufacturer last update
October 10, 2022
Active status
No
Manufacturer
Manufacturer name
NUXEN SRL
Country
Argentina
Country type
NON_EU
Address
2381 SITIO DE MONTEVIDEO LANUS
Email
info@deflex.com.ar
Authorized representative
Name
Cinterqual-Soluções de Comércio Internacional,Lda.
SRN
PT-AR-000002813
Country
Portugal
Address
Nº 4 Avenida Defensores de Chaves, Escritório Idea Spaces Lisboa
Email
cinterqualportugal@sapo.pt
Telephone
+351215838500
Regulatory information
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
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

About this record

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 07798148623481 and manufactured by NUXEN SRL in Argentina.

This page provides complete registration details including trade name (BULKFLEX ELASTIK 22 PEQUEÑO EL3 – BF47), 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.