Pure Global

HBDH2 - COFEPRIS Registration 0801R2022 SSA

Access comprehensive regulatory information for HBDH2 (HBDH2) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 0801R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on August 16, 2022.

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
0801R2022 SSA
HBDH2
COFEPRIS Analysis ID: 0801R2022 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

TESTINVITROPARALADETERMINACIÓNCUANTITATIVADELA Α‑HIDROXIBUTIRATO DESHIDROGENASA (LACTATODESHIDROGENASA‑1‑ISOENZIMA) EN SUERO Y PLASMAHUMANOS EN LOS SISTEMAS ROCHE. AGENTE DEDIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSI

English

TESTINVITRO FOR THE QUANTITATIVE DETERMINATION OF Α-HYDROXYBUTYRATE DEHYDROGENASE (LACTATE DEHYDROGENASE-1-ISOENZYME) IN HUMAN SERUM AND PLASMA IN ROCHE SYSTEMS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR EXCLUSIVE USE

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 LADETERMINACIÓN CUANTITATIVA DE LA α-HIDROXIBUTIRATODESHIDROGENASA
Trade Name (English)
REAGENT FOR THE QUANTITATIVE DETERMINATION OF α-HYDROXYBUTYRATE DEHYDROGENASE
Registration Information
Analysis ID
0801R2022 SSA
Registration Date
August 16, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.