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CRE TM PULMONAR BOSTON SCIENTIFIC. - COFEPRIS Registration 1978C2019 SSA

Access comprehensive regulatory information for CRE TM PULMONAR BOSTON SCIENTIFIC. (CRE TM PULMONAR BOSTON SCIENTIFIC.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1978C2019 SSA and manufactured by BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.. The device was registered on October 10, 2019.

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 III
1978C2019 SSA
CRE TM PULMONAR BOSTON SCIENTIFIC.
COFEPRIS Analysis ID: 1978C2019 SSA
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Product Use / Uso del Producto
Spanish

EL CATÉTER BALÓN DE DILATACIÓN PULMONAR CRETM ESTÁ INDICADO PARA DILATAR MEDIANTE ENDOSCOPÍA LAS ESTENOSIS DEL ÁRBOL RESPIRATORIO. DISPOSITIVO DE UN SOLO USO. NO REUTILIZAR, REPROCESAR O RE-ESTERILIZAR.

English

THE CRETM BALLOON PULMONARY DILATION CATHETER IS INDICATED TO DILATE THE STENOSIS OF THE RESPIRATORY TREE BY ENDOSCOPY. SINGLE-USE DEVICE. DO NOT REUSE, REPROCESS OR RE-STERILIZE.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
V. MATERIALES QUIRÚRGICOS Y DE CURACIÓN
Product Type (English)
V. SURGICAL AND HEALING MATERIALS
Trade Name (Spanish)
CATÉTER BALÓN BRANQUIAL.
Trade Name (English)
GILL BALLOON CATHETER.
Registration Information
Analysis ID
1978C2019 SSA
Registration Date
October 10, 2019
Manufacturer / Fabricante
Name (English)
BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.