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DUROLANE - COFEPRIS Registration 2139C2021 SSA

Access comprehensive regulatory information for DUROLANE (DUROLANE) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 2139C2021 SSA and manufactured by EMERGO,S.DER.L.DEC.V.. The device was registered on December 14, 2021.

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
2139C2021 SSA
DUROLANE
COFEPRIS Analysis ID: 2139C2021 SSA
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Product Use / Uso del Producto
Spanish

DUROLANEESTรINDICADOPARASUUSOENINYECCIร“N INTRAARTICULAR PARA ELTRATAMIENTO SINTOMรTICO DE LAOSTEOARTRITIS DE RODILLA LEVE AMODERADA.

English

DUROLANE IS INDICATED FOR USE IN INTRA-ARTICULAR INJECTION FOR THE SYMPTOMATIC TREATMENT OF MILD TO MODERATE KNEE OSTEOARTHRITIS.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
II. PROTESIS, ร“RTESIS Y AYUDAS FUNCIONALES
Product Type (English)
II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS
Trade Name (Spanish)
LUBRICANTE VISCOELรSTICO.
Trade Name (English)
VISCOELASTIC LUBRICANT.
Registration Information
Analysis ID
2139C2021 SSA
Registration Date
December 14, 2021
Manufacturer / Fabricante
Name (Spanish)
EMERGO,S.DER.L.DEC.V.
Name (English)
EMERGO,S.DER. L.DEC.V.