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HYDRAGEL HEMOGLOBIN (E) - COFEPRIS Registration 1669R2020 SSA

Access comprehensive regulatory information for HYDRAGEL HEMOGLOBIN (E) (HYDRAGEL HEMOGLOBIN (E)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1669R2020 SSA and manufactured by LABORATORIOS LICON, S.A.. The device was registered on December 18, 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
1669R2020 SSA
HYDRAGEL HEMOGLOBIN (E)
COFEPRIS Analysis ID: 1669R2020 SSA
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Product Use / Uso del Producto
Spanish

LOS KITS HYDRAGEL 7 HEMOGLOBIN (E) EHYDRAGEL 15 HEMOGLOBIN (E) ESTÁNINDICADOS PARA LA SEPARACIÓN DE LASHEMOGLOBINASNORMALES(AYA2)YPARALADETECCIÓNDELASPRINCIPALESVARIANTESDEHEMOGLOBINA: S O D Y C O E, MEDIANTEELECTROFORESIS EN GELES DE AGAROSATAMPONADOSALCALINOS(PH8.5). LOSKITSHYDRAGEL 7 ACID(E) HEMOGLOBIN(E) EHYDRAGEL 15 ACID(E) HEMOGLOBIN(E) ESTÁNDISEÑADOS PARA LA SEPARACIÓN DE LAHEMOGLOBINA NORMAL A, LASHEMOGLOBINAS ANORMALES S Y C Y LA

English

THE HYDRAGEL 7 HAEMOGLOBIN (E) AND HYDRAGEL 15 HAEMOGLOBIN (E) KITS ARE INDICATED FOR THE SEPARATION OF NORMAL HAEMOGLOBIN (AYA2) AND FOR THE DETECTION OF THE MAIN HAEMOGLOBIN VARIANTS: S OR D AND C OR E, BY ELECTROPHORESIS IN ALKALINE AGAROSE GELS (PH8.5). THE KITSHYDRAGEL 7 ACID(E) HEMOGLOBIN(E) EHYDRAGEL 15 ACID(E) HEMOGLOBIN(E) ARE DESIGNED FOR THE SEPARATION OF NORMAL HEMOGLOBIN A, ABNORMAL HEMOGLOBINS S AND C AND

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)
KITDEDIAGNÓSTICOINVITROPARALASEPARACIÓNDEHEMOGLOBINASY SUS VARIANTES
Trade Name (English)
DIAGNOSTIC KITINVITING FORTHE SEPARATION OF HAEMOGLOBINS AND THEIR VARIANTS
Registration Information
Analysis ID
1669R2020 SSA
Registration Date
December 18, 2020
Manufacturer / Fabricante
Name (English)
LABORATORIOS LICON, S.A.