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CALSET GDF-15. - COFEPRIS Registration 1459R2020 SSA

Access comprehensive regulatory information for CALSET GDF-15. (CALSET GDF-15.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1459R2020 SSA and manufactured by PRODUCTOS ROCHE, S.A. DEC.V.. The device was registered on October 23, 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.

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COFEPRIS Official Data
Clase I
1459R2020 SSA
CALSET GDF-15.
COFEPRIS Analysis ID: 1459R2020 SSA
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Product Use / Uso del Producto
Spanish

CALSETGDF-15SIRVEPARACALIBRARELTESTCUANTITATIVO ELECSYS GDF-15 EN LOSINMUNOANALIZADORES ROCHE. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVOENLABORATORIOSCLÍNICOSODEGABINETES.

English

CALSETGDF-15SIRVEPARACALIBRARELTESTCUANTITATIVO ELECSYS GDF-15 EN LOSINMUNOANALIZADORES ROCHE. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVOENLABORATORIOSCLÍNICOSODEGABINETES.

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)
REACTIVO CALIBRADOR.
Trade Name (English)
CALIBRATOR REAGENT.
Registration Information
Analysis ID
1459R2020 SSA
Registration Date
October 23, 2020
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DEC.V.