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GENADYNE PVA FOAM KITS. - COFEPRIS Registration 462C2021 SSA

Access comprehensive regulatory information for GENADYNE PVA FOAM KITS. (GENADYNE PVA 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 462C2021 SSA and manufactured by PROMESURGICAL, S.A.DE C.V.. The device was registered on March 19, 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
462C2021 SSA
GENADYNE PVA FOAM KITS.
COFEPRIS Analysis ID: 462C2021 SSA
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Product Use / Uso del Producto
Spanish

EL KIT DE APÓSITO DE ESPUMA PVAGENADYNE XLR8 ESTÁ DISEÑADO PARAUSARSE JUNTO CON EL SISTEMA DEASPIRACIÓN DE HERIDAS GENADYNE XLR8/XLR8+ COMO RELLENO DE HERIDAS. ELSISTEMA DE ASPIRACIÓN DE HERIDASGENADYNE XLR8/ XLR8+ ESTÁ INDICADOPARAPACIENTESQUESEBENEFICIARÍANDEUN DISPOSITIVO DE SUCCIÓN,PARTICULARMENTEPORQUEELDISPOSITIVOPUEDE PROMOVER LA CURACIÓN DEHERIDAS.

English

THE Pvagenadyne XLR8 FOAM DRESSING KIT IS DESIGNED TO BE USED IN CONJUNCTION WITH THE GENADYNE XLR8/XLR8+ WOUND SUCTION SYSTEM AS A WOUND FILLER. THE GENADYNE XLR8/ XLR8+ WOUND ASPIRATION SYSTEM IS INDICATED FOR PATIENTS WHO WOULD BENEFIT FROM A SUCTION DEVICE, PARTICULARLY AS THE DEVICE CAN PROMOTE WOUND HEALING.

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.
Trade Name (English)
FOAM DRESSING FOR NEGATIVE PRESSURE WOUND TREATMENT EQUIPMENT.
Registration Information
Analysis ID
462C2021 SSA
Registration Date
March 19, 2021
Manufacturer / Fabricante
Name (English)
PROMESURGICAL, S.A.DE C.V.