Pure Global

A1CARE HBA1C - COFEPRIS Registration 510R2022 SSA

Access comprehensive regulatory information for A1CARE HBA1C (A1CARE HBA1C) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 510R2022 SSA and manufactured by AXMILAB, S.A. DE C.V.. The device was registered on June 17, 2022.

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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase I
510R2022 SSA
A1CARE HBA1C
COFEPRIS Analysis ID: 510R2022 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

LASOLUCIÓNDECONTROLA1CAREHBA1CESTÁDISEÑADAPARA SERUTILIZADA COMOMATERIAL DE CONTROL DECALIDAD PARA CONTROLAR EL RENDIMIENTO Y LAPRECISIÓN DE LOS MÉTODOS DE DETERMINACIÓN DEHEMOGLOBINA A1C.

English

LASOLUCIÓNDECONTROLA1CAREHBA1CESTÁDISEÑADAPARA BE USED AS QUALITY CONTROL MATERIAL TO MONITOR THE PERFORMANCE AND ACCURACY OF HEMOGLOBIN A1C DETERMINATION METHODS.

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)
SOLUCIÓN DE CONTROL
Trade Name (English)
CONTROL SOLUTION
Registration Information
Analysis ID
510R2022 SSA
Registration Date
June 17, 2022
Manufacturer / Fabricante
Name (Spanish)
AXMILAB, S.A. DE C.V.
Name (English)
AXMILAB, S.A. DE C.V.