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HC-CALIBRATOR - COFEPRIS Registration 2724R2018 SSA

Access comprehensive regulatory information for HC-CALIBRATOR (HC-CALIBRATOR) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2724R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on December 06, 2018.

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
2724R2018 SSA
HC-CALIBRATOR
COFEPRIS Analysis ID: 2724R2018 SSA
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Product Use / Uso del Producto
Spanish

HC-CALIBRATOR ES UN REACTIVO COMPUESTO DE ERITROCITOS HUMANOS, LEUCOCITOS Y PLAQUETAS DE MAMÍFEROS SUSPENDIDAS EN UN FLUIDO SIMILAR AL PLASMA CON AGENTES PRESERVANTES. AGENTES DE DIAGNÓSTICO PARA USO IN VITRO, PARA USO EXCLUSIVO DE LABORATORIO CLÍNICO O

English

HC-CALIBRATOR IS A REAGENT COMPOSED OF HUMAN ERYTHROCYTES, LEUKOCYTES AND MAMMALIAN PLATELETS SUSPENDED IN A PLASMA-LIKE FLUID WITH PRESERVATIVE AGENTS. DIAGNOSTIC AGENTS FOR IN VITRO USE, FOR CLINICAL LABORATORY USE ONLY, OR

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)
CALIBRADOR DE HEMATOLOGÍA PARA HUMACOUNT 30TS, HUMACOUNT 60TS, HUMACOUNT 80TS Y HUMACOUNT 5L.
Trade Name (English)
HEMATOLOGY CALIBRATOR FOR HUMACOUNT 30TS, HUMACOUNT 60TS, HUMACOUNT 80TS AND HUMACOUNT 5L.
Registration Information
Analysis ID
2724R2018 SSA
Registration Date
December 06, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.