HELIFANPLUS FANCI3 - HELIFANPLUS - INVIMA Registration 561eba481a50024d79379f2bf5cd168e
Access comprehensive regulatory information for HELIFANPLUS FANCI3 - HELIFANPLUS (HELIFANPLUS FANCI3 - HELIFANPLUS ) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 561eba481a50024d79379f2bf5cd168e and manufactured by BYO COLOMBIA S.A.S.. The device was registered on April 25, 2033.
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.
EL USO PREVISTO DE HELIFANPLUS (FANCI3) ES MEDIR DE FORMA NO INVASIVA LOS CAMBIOS EN LA RELACIÓN 13C/12C EN EL CO2 DEL AIRE EXHALADO DESPUÉS DE LA INGESTA DE UN SUSTRATO ENRIQUECIDO CON EL ISÓTOPO ESTABLE 13C. EL NIVEL DE CAMBIO EN LA RELACIÓN 13C/12C PUEDE SER INDICATIVO DE UN CAMBIO FISIOLÓGICO O METABÓLICO EN LA CONDICIÓN DEL PACIENTE.
THE INTENDED USE OF HELIFANPLUS (FANCI3) IS TO NON-INVASIVELY MEASURE CHANGES IN THE 13C/12C RATIO IN EXHALED AIR CO2 AFTER INGESTION OF A SUBSTRATE ENRICHED WITH THE STABLE ISOTOPE 13C. THE LEVEL OF CHANGE IN THE 13C/12C RATIO MAY BE INDICATIVE OF A PHYSIOLOGICAL OR METABOLIC CHANGE IN THE PATIENT'S CONDITION.