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CALIBRADORES HEMATOLÓGICOS - COFEPRIS Registration 1745R2021 SSA

Access comprehensive regulatory information for CALIBRADORES HEMATOLÓGICOS (HAEMATOLOGICAL CALIBRATORS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1745R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on April 11, 2021.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), 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 I
1745R2021 SSA
CALIBRADORES HEMATOLÓGICOS
COFEPRIS Analysis ID: 1745R2021 SSA
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Product Use / Uso del Producto
Spanish

LOS CALIBRADORES HEMATOLÓGICOS SEEMPLEANPARACALIBRARY VERIFICARLOSENSAYOS EN LOS ANALIZADORES DEHEMATOLOGÍA DE SYSMEX. AGENTE DEDIAGNÓSTICOS PARA USO IN VITRO. PARAUSOEXCLUSIVOENLABORATORIOSCLÍNICOSO DE GABINETE.

English

HAEMATOLOGICAL CALIBRATORS ARE USED TO VERIFY ASSAYS ON SYSMEX HAEMATOLOGY ANALYSERS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR EXCLUSIVE USE IN CLINICAL LABORATORIES OR CABINET.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CALIBRADORES
Trade Name (English)
CALIBRATORS
Registration Information
Analysis ID
1745R2021 SSA
Registration Date
April 11, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.