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GENADYNE SILVER FOAM KITS - COFEPRIS Registration 1944C2021 SSA

Access comprehensive regulatory information for GENADYNE SILVER FOAM KITS (GENADYNE SILVER FOAM KITS) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1944C2021 SSA and manufactured by PROMESURGICAL, S.A.DE C.V.. The device was registered on November 24, 2021.

This page provides complete registration details including product type (V. SURGICAL AND HEALING MATERIALS), 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
1944C2021 SSA
GENADYNE SILVER FOAM KITS
COFEPRIS Analysis ID: 1944C2021 SSA
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Product Use / Uso del Producto
Spanish

GENADYNE SILVER FOAM KITS ESTÁDISEÑADOPARAUSARSECONLAFAMILIADESISTEMAS DE TERAPIA DE HERIDAS DEPRESIÓN NEGATIVA GENADYNE PARAAYUDAR A PROMOVER LA CURACIÓN DEHERIDAS. EL APÓSITO ES UNA BARRERAEFICAZ CONTRA LA PENETRACIÓNBACTERIANAYPUEDEAYUDARAREDUCIRLAINFECCIÓNENHERIDASCRÓNICAS,AGUDAS,TRAUMÁTICAS, SUBAGUDAS Y DEHISCENTES,ÚLCERAS DIABÉTICAS, ÚLCERAS PORPRESIÓN, COLGAJOS, INJERTOS YQUEMADURAS DE ESPESOR PARCIAL.PRODUCTO ESTÉRIL, CON ÓXIDO DE ETILENO.

English

GENADYNE SILVER FOAM KITS ARE DESIGNED FOR USE WITH THE GENADYNE FAMILY OF NEGATIVE DEPRESSION WOUND THERAPY SYSTEMS TO HELP PROMOTE WOUND HEALING. THE DRESSING IS AN EFFECTIVE BARRIER AGAINST BACTERIAL PENETRATION AND CAN HELP REDUCE INFECTION IN CHRONIC, ACUTE, TRAUMATIC, SUBACUTE AND DEHISCENT WOUNDS, DIABETIC ULCERS, PRESSURE ULCERS, FLAPS, GRAFTS AND PARTIAL-THICKNESS BURNS. STERILE PRODUCT, WITH ETHYLENE OXIDE.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
V. MATERIALES QUIRÚRGICOS Y DE CURACIÓN
Product Type (English)
V. SURGICAL AND HEALING MATERIALS
Trade Name (Spanish)
APÓSITO DE ESPUMA PARA EQUIPO DETRATAMIENTO DE HERIDAS POR PRESIÓNNEGATIVA, ANTIMICROBIANO
Trade Name (English)
FOAM DRESSING FOR NEGATIVE PRESSURE WOUND TREATMENT EQUIPMENT, ANTIMICROBIAL
Registration Information
Analysis ID
1944C2021 SSA
Registration Date
November 24, 2021
Manufacturer / Fabricante
Name (English)
PROMESURGICAL, S.A.DE C.V.