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SURETEK. - COFEPRIS Registration 1014C2020 SSA

Access comprehensive regulatory information for SURETEK. (SURETEK.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1014C2020 SSA and manufactured by BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.. The device was registered on July 31, 2020.

This page provides complete registration details including product type (II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase III
1014C2020 SSA
SURETEK.
COFEPRIS Analysis ID: 1014C2020 SSA
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DJ Fang

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Product Use / Uso del Producto
Spanish

CUBIERTADETRÉPANOSURETEKESUNAPIEZADE ANCLAJE DE ELECTRODO QUE SE UTILIZACONELSISTEMADEESTIMULACIÓNCEREBRALPROFUNDA DE BOSTON SCIENTIFIC.DISPOSITIVODEUNSOLOUSO,NOREUTILIZARÓ RE-ESTÉRILIZAR

English

COVEROVERSURETEK IS AN ELECTRODE ANCHOR PIECE USED WITH BOSTON SCIENTIFIC'S DEEP BRAIN STIMULATION SYSTEM. DEVICEDEUNSOLOUSO,NOREUSARÓ RE-ESTÉRILIZAR

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
II. PROTESIS, ÓRTESIS Y AYUDAS FUNCIONALES
Product Type (English)
II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS
Trade Name (Spanish)
CUBIERTA DE TRÉPANO.
Trade Name (English)
TREPHINE COVER.
Registration Information
Analysis ID
1014C2020 SSA
Registration Date
July 31, 2020
Manufacturer / Fabricante
Name (English)
BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.