Pure Global

AMIK2 - COFEPRIS Registration 370R2020 SSA

Access comprehensive regulatory information for AMIK2 (AMIK2) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 370R2020 SSA and manufactured by PRODUCTOS ROCHE, S.A. DEC.V.. The device was registered on March 24, 2020.

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
370R2020 SSA
AMIK2
COFEPRIS Analysis ID: 370R2020 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

PRUEBA IN VITRO PARA LA DETERMINACIÓNCUANTITATIVA DE AMICACINA EN SUERO YPLASMAENLOSSISTEMASROCHE. AGENTEDEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVOENLABORATORIOSCLÍNICOSODEGABINETES.

English

IN VITRO TEST FOR THE QUANTITATIVE DETERMINATION OF AMIKACIN IN SERUM AND PLASMA IN ROCHE SYSTEMS. DIAGNOSTICAGENTFORUSEINVITRO. FOR exclusive use in clinical laboratories or cabinets.

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)
PRUEBA PARA LA DETERMINACIÓNDE AMICACINA
Trade Name (English)
TEST FOR THE DETERMINATION OF AMIKACIN
Registration Information
Analysis ID
370R2020 SSA
Registration Date
March 24, 2020
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DEC.V.