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DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE - EUDAMED Registration 07908516807188

Access comprehensive regulatory information for DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE 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 07908516807188 and manufactured by 3R Indústria E Comércio LTDA in Brazil.

This page provides complete registration details including trade name (DIAMOND BUR 4200F - Box with 10), 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.

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EUDAMED Official Data
Class I
07908516807188
No
DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE
Trade Name: DIAMOND BUR 4200F - Box with 10
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Device Description (EMDN)

DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010501
Trade Name
DIAMOND BUR 4200F - Box with 10
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07908516807188
Basic UDI
79085168diamondbursD6
Version Date
August 28, 2023
Manufacturer Last Update
April 11, 2023
Active Status
No
Manufacturer
Country
Brazil
Country Type
NON_EU
Address
290 R PTOLOMEU Sao Paulo
Email
catia@3r.ind.br
Authorized Representative
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
Portugal
Device Characteristics
Human Tissues
No
Animal Tissues
No