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CON 3 - COFEPRIS Registration 1212R2021 SSA

Access comprehensive regulatory information for CON 3 (WITH 3) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1212R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on November 08, 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
1212R2021 SSA
CON 3
COFEPRIS Analysis ID: 1212R2021 SSA
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Product Use / Uso del Producto
Spanish

CONTROL 3 SIRVE PARA EL CONTROL DECALIDADDEPRUEBASDECOAGULACIร“NENLOS ANALIZADORES DE ROCHE INDICADOS.AGENTES DE DIAGNร“STICO PARA USO INVITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLรNICOS O DE GABINETES

English

CONTROL 3 IS USED FOR THE QUALITY CONTROL OF COAGULATION TESTS IN THE INDICATED ROCHE ANALYSERS. DIAGNOSTIC AGENTS FOR INVITRO USE. FOR USE IN CLINICAL LABORATORIES OR CABINETS ONLY

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVODECONTROLDECALIDADPARAPRUEBAS DE COAGULACIร“N
Trade Name (English)
QUALITY CONTROL REAGENT FOR COAGULATION TESTS
Registration Information
Analysis ID
1212R2021 SSA
Registration Date
November 08, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.