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OSSBUILDER KIT - COFEPRIS Registration 1416E2021 SSA

Access comprehensive regulatory information for OSSBUILDER KIT (OSSBUILDER KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1416E2021 SSA and manufactured by HIOSSEN DE MÉXICO,S.A. DE C.V.. The device was registered on September 15, 2021.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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 II
1416E2021 SSA
OSSBUILDER KIT
COFEPRIS Analysis ID: 1416E2021 SSA
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Product Use / Uso del Producto
Spanish

ELOSSBUILDERKITESTÁINDICADOENLOSPROCEDIMIENTOS QUIRÚRGICOS DEREGENERACIÓN ÓSEA GUIADA (GBR) DELSITIO CON DEFECTO ÓSEO ALVEOLAR,MEDIANTE LA UTILIZACIÓN DECOMPONENTES Y HERRAMIENTASQUIRÚRGICAS DE GBR.

English

ELOSSBUILDERKIT IS INDICATED IN SURGICAL PROCEDURES FOR GUIDED BONE REGENERATION (GBR) OF THE SITE WITH ALVEOLAR BONE DEFECT, USING GBR SURGICAL COMPONENTS AND TOOLS.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
INSTRUMENTAL QUIRÚRGICO EMPLEADOEN LA REGENERACIÓN ÓSEA GUIADA
Trade Name (English)
SURGICAL INSTRUMENTS USED IN GUIDED BONE REGENERATION
Registration Information
Analysis ID
1416E2021 SSA
Registration Date
September 15, 2021
Manufacturer / Fabricante
Name (English)
HIOSSEN DE MÉXICO,S.A. DE C.V.