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Colombia INVIMA registration 20326549

OPTILUME BPH CATHETER SYSTEM UROTRONICSISTEMA DE CATETER DE DILATIACION URETRAL

UROTRONIC INCIIIColombia INVIMA
VerifiedINVIMA · official registry
Product use / Uso del producto
Spanish

EL SISTEMA DE CATÉTER BPH OPTILUME ESTÁ INDICADO PARA EL TRATAMIENTO DE LOS SÍNTOMAS URINARIOS OBSTRUCTIVOS ASOCIADOS A LA HIPERPLASIA BENIGNA DE PRÓSTATA (HBP) EN HOMBRES =50 AÑOS DE EDAD

Device classification
Registered product (Spanish)
OPTILUME BPH CATHETER SYSTEM UROTRONICSISTEMA DE CATETER DE DILATIACION URETRAL
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Risk class / Clase de riesgo
III
Product group (Spanish)
MEDICO QUIRURGICOS
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Trade name / Marca
OPTILUME BPH CATHETER SYSTEM
Commercial presentation / Presentación comercial
Caja(s) 1 Kit(s)
Registration information
Sanitary registration
20326549
Expediente
20326549
Status / Estado
En Estudio
Registration holder / Titular
Name
UROTRONIC INC
Associated party / Rol
Name
UROTRONIC INC
Role
FABRICANTE
Country
ESTADOS UNIDOS DE AMÉRICA
Manufacturer
UROTRONIC INC
About this record

Access comprehensive regulatory information for OPTILUME BPH CATHETER SYSTEM UROTRONICSISTEMA DE CATETER DE DILATIACION URETRAL in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA sanitary registration 20326549, held by UROTRONIC INC and associated with UROTRONIC INC (FABRICANTE).

This page provides complete registration details including product group (MEDICO QUIRURGICOS), holder and associated-party information, and regulatory 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.