Pure Global

UF-CELLPACK™ - COFEPRIS Registration 1845R2018 SSA

Access comprehensive regulatory information for UF-CELLPACK™ (UF-CELLPACK™) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1845R2018 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on August 01, 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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase I
1845R2018 SSA
UF-CELLPACK™
COFEPRIS Analysis ID: 1845R2018 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

UF-CELLPACK CR / SF ES PARA USO EXCLUSIVO JUNTO CON EL UF-FLUOROCELL CR / SF, Y SIRVE PARA MARCAR LOS ELEMENTOS FORMADOS EN LA ORINA (O EN FLUIDOS CORPORALES, COMO EL LÍQUIDO CEFALORRAQUÍDEO) PARA LA DETERMINACIÓN DE MATERIALES QUE NO TIENEN NÚCLEO (ERITR

English

UF-CELLPACK CR / SF IS FOR EXCLUSIVE USE IN CONJUNCTION WITH THE UF-FLUOROCELL CR / SF, AND SERVES TO MARK THE ELEMENTS FORMED IN URINE (OR IN BODY FLUIDS, SUCH AS CEREBROSPINAL FLUID) FOR THE DETERMINATION OF MATERIALS THAT HAVE NO CORE (ERITR

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 PARA MARCAR ELEMENTOS QUE NO CONTIENEN NÚCLEO EN FLUÍDOS CORPORALES.
Trade Name (English)
REAGENT FOR MARKING NON-CORE ELEMENTS IN BODY FLUIDS.
Registration Information
Analysis ID
1845R2018 SSA
Registration Date
August 01, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.