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ABDOMINAL DRESSING KIT. - COFEPRIS Registration 172C2021 SSA

Access comprehensive regulatory information for ABDOMINAL DRESSING KIT. (ABDOMINAL DRESSING 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 172C2021 SSA and manufactured by PROMESURGICAL, S.A.DE C.V.. The device was registered on February 09, 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
172C2021 SSA
ABDOMINAL DRESSING KIT.
COFEPRIS Analysis ID: 172C2021 SSA
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Product Use / Uso del Producto
Spanish

EL ABDOMINAL DRESSING KIT, ESTÁINDICADO PARA SU USO EN CONJUNCIÓNCON EL SISTEMA XLR8+ PARA NPWT DEGENADYNE, PARA LOS PACIENTES QUETIENEN HERIDAS ABDOMINALES ABIERTASCON VÍSCERAS Y ÓRGANOS EXPUESTOS,INCLUYENDO A LOS PACIENTES CON ELSÍNDROME COMPARTIMENTAL ABDOMINAL,LA ESPUMA DE APÓSITO DE HERIDAABDOMINAL XLR8 SE UTILIZA PARA ELPUENTE TEMPORAL DE ABERTURAS DE LAPARED ABDOMINAL, DONDE EL CIERREPRIMARIO NO ES POSIBLE Y/O SE PUEDENNECESITAR ENTRADAS ABDOMINALES

English

THE ABDOMINAL DRESSING KIT, IS INDICATED FOR USE IN CONJUNCTION WITH THE XLR8+ SYSTEM FOR NPWT DEGENADYNE, FOR PATIENTS WHO HAVE OPEN ABDOMINAL WOUNDS WITH VISCERA AND EXPOSED ORGANS, INCLUDING PATIENTS WITH ABDOMINAL COMPARTMENT SYNDROME, XLR8 ABDOMINAL WOUND DRESSING FOAM IS USED FOR TEMPORARY BRIDGE OF ABDOMINAL WALL OPENINGS, WHERE PRIMARY CLOSURE IS NOT POSSIBLE AND/OR ABDOMINAL ENTRANCES MAY BE NEEDED.

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 PARA ABDOMEN ABIERTO DETRATAMIENTO DE HERIDAS POR PRESIÓNNEGATIVA.
Trade Name (English)
DRESSING FOR OPEN ABDOMEN OF TREATMENT OF WOUNDS BY NEGATIVE PRESSURE.
Registration Information
Analysis ID
172C2021 SSA
Registration Date
February 09, 2021
Manufacturer / Fabricante
Name (English)
PROMESURGICAL, S.A.DE C.V.