Mexico COFEPRIS registration 1170E2019 SSA

MICROSCOPIO ESPECULAR NIDEK CEM530

EN: NIDEK CEM530 SPULAR MICROSCOPE
Mexico flagMexico·Clase II·I. MEDICAL EQUIPMENT·S4OPTIK, S.A. DE C.V.·Registered May 28, 2019
Product Use / Uso del Producto
Spanish

ESTE DISPOSITIVO ESTÁ DESTINADO PARA OBSERVAR, CAPTURAR O REGISTRAR IMÁGENES DEL OJO Y APÉNDICES PARA PROPORCIONAR INFORMACIÓN DE IMAGEN ELECTRÓNICA POR DIAGNÓSTICO.

English

THIS DEVICE IS INTENDED TO OBSERVE, CAPTURE, OR RECORD IMAGES OF THE EYE AND APPENDICES TO PROVIDE ELECTRONIC IMAGING INFORMATION BY DIAGNOSIS.

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
MICROSCOPIO OFTALMICO
Trade Name (English)
OPHTHALMIC MICROSCOPE
Registration information
Analysis ID
1170E2019 SSA
Registration Date
May 28, 2019
Manufacturer / Fabricante
Name (Spanish)
S4OPTIK, S.A. DE C.V.
Name (English)
S4OPTIK, S.A. DE C.V.
About this record

Access comprehensive regulatory information for MICROSCOPIO ESPECULAR NIDEK CEM530 (NIDEK CEM530 SPULAR MICROSCOPE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1170E2019 SSA and manufactured by S4OPTIK, S.A. DE C.V.. The device was registered on May 28, 2019.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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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