Mexico COFEPRIS registration 350E2020 SSA

AUTOREFRACTO-QUERATÓMETRONIDEK, MODELO: ARK-F

EN: AUTOREFRACTO-KERATOMETERNIDEK, MODEL: ARK-F
Mexico flagMexico·Clase II·I. MEDICAL EQUIPMENT·S4OPTIK, S.A. DE C.V.·Registered March 19, 2020
Product Use / Uso del Producto
Spanish

PARA MEDIR ERRORES DE REFRACCIÓNOBJETIVAYELRADIODECURVATURACORNEALDEL OJO DEL PACIENTE. ESTE DISPOSITIVOTAMBIÉN OFRECE MODO DERETROILUMINACIÓN PARA OBSERVAR LACONDICIÓN DEL MEDIO OCULAR Y MIDE LAAMPLITUD DE ACOMODACIÓN.

English

TO MEASURE OBJECTIVE REFRACTIVE ERRORS AND THE CORNEAL RADIUS OF CURVATURE OF THE PATIENT'S EYE. THIS DEVICE ALSO OFFERS BACKLIGHT MODE TO OBSERVE THE CONDITION OF THE OCULAR ENVIRONMENT AND MEASURES THE AMPLITUDE OF ACCOMMODATION.

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
REFRACTO-QUERATÓMETRO
Trade Name (English)
REFRACTO-KERATOMETER
Registration information
Analysis ID
350E2020 SSA
Registration Date
March 19, 2020
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 AUTOREFRACTO-QUERATÓMETRONIDEK, MODELO: ARK-F (AUTOREFRACTO-KERATOMETERNIDEK, MODEL: ARK-F) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 350E2020 SSA and manufactured by S4OPTIK, S.A. DE C.V.. The device was registered on March 19, 2020.

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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