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DORNIER COMPACT SIGMA - COFEPRIS Registration 1464E2018 SSA

Access comprehensive regulatory information for DORNIER COMPACT SIGMA (DORNIER COMPACT SIGMA) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1464E2018 SSA and manufactured by LEVBETH MEDICAL S.A. DE C.V.. The device was registered on June 11, 2018.

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 III
1464E2018 SSA
DORNIER COMPACT SIGMA
COFEPRIS Analysis ID: 1464E2018 SSA
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Product Use / Uso del Producto
Spanish

PARA LA FRAGMENTACIร“N DE CรLCULOS DE LAS VรAS URINARIAS, CรLCULOS RENALES CALICIALES, CรLCULOS RENALES Pร‰LVICOS Y CรLCULOS DE LAS VรAS URINARIAS ALTAS.

English

FOR FRAGMENTATION OF URINARY TRACT STONES, CALICIAL KIDNEY STONES, PELVIC KIDNEY STONES, AND UPPER URINARY TRACT STONES.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
I. EQUIPO Mร‰DICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
LITOTRIPTOR
Trade Name (English)
LITOTRIPTOR
Registration Information
Analysis ID
1464E2018 SSA
Registration Date
June 11, 2018
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL S.A. DE C.V.