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DRILL's - EUDAMED Registration *+D99484500209*

Access comprehensive regulatory information for DRILL's 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 *+D99484500209* and manufactured by SYSTHEX - SISTEMAS DE IMPLANTES OSSEO INTEGRADO LTDA in Brazil.

This page provides complete registration details including trade name (Drill Extension), 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
*+D99484500209*
No
DRILL's
Trade Name: Drill Extension
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Device Description (EMDN)

SURGICAL DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010399
Trade Name
Drill Extension
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
*+D99484500209*
Basic UDI
B-*+D99484500209*
Version Date
December 11, 2024
Manufacturer Last Update
July 17, 2024
Active Status
No
Manufacturer
Country
Brazil
Country Type
NON_EU
Address
586 PROCร“PIO FERREIRA MARTINS CURITIBA
Email
regulatorio01@systhex.com.br
Authorized Representative
SRN
PT-AR-000042998
Country
Portugal
Address
68 B RUA PINHEIRO CHAGAS LISBON
Email
gerencia@sbpportugal.pt
Telephone
+351 914 320 774
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:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No