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REFRACTOR, MARCA: NIDEK, MODELO: RT-6100 - COFEPRIS Registration 2077E2019 SSA

Access comprehensive regulatory information for REFRACTOR, MARCA: NIDEK, MODELO: RT-6100 (REFRACTOR, MAKE: NIDEK, MODEL: RT-6100) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2077E2019 SSA and manufactured by S4OPTIK, S.A. DE C.V.. The device was registered on November 04, 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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COFEPRIS Official Data
Clase I
2077E2019 SSA
REFRACTOR, MARCA: NIDEK, MODELO: RT-6100
COFEPRIS Analysis ID: 2077E2019 SSA
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Product Use / Uso del Producto
Spanish

EL REFRACTOR RT-100 ES UN DISPOSITIVO QUE PROPORCIONA UN MEDIO PARA POSICIONAR LAS LENTES ESFร‰RICAS Y CILรNDRICAS, PRISMAS Y OTROS DISPOSITIVOS ร“PTICOS FRENTE A LOS OJOS DEL PACIENTE, PARA DETERMINAR EL ERROR DE REFRACCIร“N Y LAS FUNCIONES BINOCULARES. TAM

English

THE RT-100 REFRACTOR IS A DEVICE THAT PROVIDES A MEANS TO POSITION SPHERICAL AND CYLINDRICAL LENSES, PRISMS AND OTHER OPTICAL DEVICES IN FRONT OF THE PATIENT'S EYES, TO DETERMINE REFRACTIVE ERROR AND BINOCULAR FUNCTIONS. TAM

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO Mร‰DICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
REFRACTOR, DISPOSITIVO DE PRUEBA OFTรLMICA
Trade Name (English)
REFRACTOR, OPHTHALMIC TESTING DEVICE
Registration Information
Analysis ID
2077E2019 SSA
Registration Date
November 04, 2019
Manufacturer / Fabricante
Name (Spanish)
S4OPTIK, S.A. DE C.V.
Name (English)
S4OPTIK, S.A. DE C.V.