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FOTOCOAGULADOR LÁSER DE USO OFTÁLMICO - COFEPRIS Registration 1025E2019 SSA

Access comprehensive regulatory information for FOTOCOAGULADOR LÁSER DE USO OFTÁLMICO (LASER PHOTOCOAGULATOR FOR OPHTHALMIC USE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1025E2019 SSA and manufactured by S4OPTIK, S.A. DE C.V.. The device was registered on May 16, 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 II
1025E2019 SSA
FOTOCOAGULADOR LÁSER DE USO OFTÁLMICO
COFEPRIS Analysis ID: 1025E2019 SSA
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Product Use / Uso del Producto
Spanish

EL FOTOCOAGULADOR LÁSER VERDE, MARCA: NIDEK, MODELO: GYC-500 ESTÁ DISEÑADO PARA SER UTILIZADO EN PROCEDIMIENTOS QUIRÚRGICOS OFTÁLMICOS, QUE INCLUYEN FOTOCOAGULACIÓN RETINAL Y MACULAR, IRIDOTOMÍA Y TRABECULOPLASTIA.

English

THE GREEN LASER PHOTOCOAGULATOR, BRAND: NIDEK, MODEL: GYC-500 IS DESIGNED TO BE USED IN OPHTHALMIC SURGICAL PROCEDURES, INCLUDING RETINAL AND MACULAR PHOTOCOAGULATION, IRIDOTOMY AND TRABECULOPLASTY.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
EQUIPO MÉDICO OFTALMOLÓGICO NIDEK
Trade Name (English)
NIDEK OPHTHALMOLOGICAL MEDICAL TEAM
Registration Information
Analysis ID
1025E2019 SSA
Registration Date
May 16, 2019
Manufacturer / Fabricante
Name (Spanish)
S4OPTIK, S.A. DE C.V.
Name (English)
S4OPTIK, S.A. DE C.V.