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RIBO-KER-SOLUCIÓN OFTÁLMICA PARA EL CROSS-LINKING DE LA CÓRNEA - INVIMA Registration a028e290bbd792cf7c9acd24443b5e42

Access comprehensive regulatory information for RIBO-KER-SOLUCIÓN OFTÁLMICA PARA EL CROSS-LINKING DE LA CÓRNEA (RIBO-KER-OPHTHALMIC SOLUTION FOR CORNEAL CROSS-LINKING) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID a028e290bbd792cf7c9acd24443b5e42 and manufactured by REPRESENTACIONES OPTICAS COLOMBIANAS S.A - ROCOL S.A... The device was registered on March 24, 2031.

This page provides complete registration details including product type (SURGICAL DOCTOR), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
III
a028e290bbd792cf7c9acd24443b5e42
RIBO-KER-SOLUCIÓN OFTÁLMICA PARA EL CROSS-LINKING DE LA CÓRNEA
INVIMA Analysis ID: a028e290bbd792cf7c9acd24443b5e42
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Product Use / Uso del Producto
Spanish

RIBO-KER ES UN DISPOSITIVO MÉDICO CE TERAPÉUTICO DE USO TÓPICO PARA EL CROSS-LINKING CORNEAL. ES UNA SOLUCIÓN OFTÁLMICA A BASE DE RIBOFLAVINA FOSFATO. LA SOLUCIÓN PERMITE PRACTICAR EL TRATAMIENTO DE CROSS-LINKING CORNEAL DE QUERATOCONOS Y/O ECTASIAS.INDICACIONES: RIBO-KER SE APLICA EN COMBINACIÓN CON UNA FUENTE LUMINOSA UV-A DE USO OFTÁLMICO PARA PERMITIR EL CROSS-LINKING CORNEAL.INDICACIONES ELECTIVAS:- QUERATOCONO Y/O ECTASIA SECUNDARIA, CLÍNICA, TOPOGRÁFICA Y PAQUIMÉTRICAMENTE DOCUMENTADOS;- QUERATOCONO PROGRESIVO CLÍNICA E INSTRUMENTALMENTE DOCUMENTADO;- QUERATOCONO 1°-2°-3° ESTADIO EVOLUTIVO;- QUERATOCONO CON CÓRNEA TRANSPARENTE A LA BIOMICROSCOPÍA (CLEAR CORNEA). INDICACIONES ADICIONALES:- QUERATOCONO NO EVOLUTIVO EN PACIENTES CON ESCASA CONFORMEDAD DE LA CORRECCIÓN ÓPTICA; - QUERATOCONO EVOLUTIVO EN EDAD PEDIÁTRICA;- QUERATOCONO CON CURVATURA CORNEAL ? 62 D;- QUERATOCONO CON ESTRÍAS DE VOGT;- QUERATOCONO CON INTOLERANCIA A LAS LENTES DE CONTACTO;- QUERATOCONO CON EMPEORAMIENTO SUBJETIVO, NO INSTRUMENTALMENTE EVIDENTE, EN PACIENTES INTOLERANTES A LA CORRECCIÓN ÓPTICA CON GAFAS Y/O LENTES DE CONTACTO.

English

RIBO-KER IS A TOPICAL THERAPEUTIC MEDICAL DEVICE FOR CORNEAL CROSS-LINKING. IT IS AN OPHTHALMIC SOLUTION BASED ON RIBOFLAVIN PHOSPHATE. THE SOLUTION ALLOWS TO PRACTICE THE TREATMENT OF CORNEAL CROSS-LINKING OF KERATOCONUS AND / OR ECTASIAS. INDICATIONS: RIBO-KER IS APPLIED IN COMBINATION WITH A UV-A LIGHT SOURCE FOR OPHTHALMIC USE TO ALLOW CORNEAL CROSS-LINKING. ELECTIVE INDICATIONS:- KERATOCONUS AND/OR SECONDARY, CLINICALLY, TOPOGRAPHICALLY AND PACHYMETRICALLY DOCUMENTED ECTASIA;- PROGRESSIVE KERATOCONUS CLINICALLY AND INSTRUMENTALLY DOCUMENTED;- KERATOCONUS 1°-2°-3° EVOLUTIONARY STAGE;- KERATOCONUS WITH TRANSPARENT CORNEA ON BIOMICROSCOPY (CLEAR CORNEA). ADDITIONAL INDICATIONS:- NON-EVOLUTIONARY KERATOCONUS IN PATIENTS WITH POOR CONFORMITY OF OPTICAL CORRECTION; - KERATOCONUS EVOLUTIONARY IN PEDIATRIC AGE;- KERATOCONUS WITH CORNEAL CURVATURE ? 62 D;- KERATOCONUS WITH VOGT STRIAE;- KERATOCONUS WITH INTOLERANCE TO CONTACT LENSES;- KERATOCONUS WITH SUBJECTIVE WORSENING, NOT INSTRUMENTALLY EVIDENT, IN PATIENTS INTOLERANT TO OPTICAL CORRECTION WITH GLASSES AND / OR CONTACT LENSES.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
a028e290bbd792cf7c9acd24443b5e42
Expire Date
March 24, 2031
Authorized Company / Fabricante
Name (English)
REPRESENTACIONES OPTICAS COLOMBIANAS S.A - ROCOL S.A..