BLUEPHASE® STYLE 20I - BLUEPHASE STYLE 20I 100-240V - INVIMA Registration 5fd46a28d7a767836e779dd5689aeafc
Access comprehensive regulatory information for BLUEPHASE® STYLE 20I - BLUEPHASE STYLE 20I 100-240V (BLUEPHASE® STYLE 20I - BLUEPHASE STYLE 20I 100-240V) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 5fd46a28d7a767836e779dd5689aeafc and manufactured by IVOCLAR VIVADENT AG. The device was registered on April 14, 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.
"ESTÁ INDICADO PARA LA POLIMERIZACIÓN DE MATERIALES DENTALES FOTOPOLIMERIZABLES INMEDIATAMENTE EN LA CAVIDAD ORAL DE LOS PACIENTES. EL LUGAR DE APLICACIÓN PREVISTO ES EN LA CLÍNICA DENTAL, EN LA CONSULTA MÉDICA O EN EL HOSPITAL POR PARTE DEL ODONTÓLOGO O DEL AUXILIAR DE ODONTOLOGÍA. EL USO PREVISTO TAMBIÉN INCLUYE LA OBSERVACIÓN DE LAS NOTAS Y NORMAS DE LAS INSTRUCCIONES DE USO. LA LÁMPARA DE POLIMERIZACIÓN SÓLO DEBE SER EMPLEADA POR PROFESIONALES CAPACITADOS." _x000D_ _x000D_ _x000D_
"IT IS INDICATED FOR THE POLYMERIZATION OF PHOTOPOLYMERIZABLE DENTAL MATERIALS IMMEDIATELY IN THE ORAL CAVITY OF PATIENTS. THE INTENDED PLACE OF APPLICATION IS IN THE DENTAL CLINIC, IN THE DOCTOR'S OFFICE OR IN THE HOSPITAL BY THE DENTIST OR DENTAL ASSISTANT. THE INTENDED USE ALSO INCLUDES OBSERVING THE NOTES AND RULES OF THE INSTRUCTIONS FOR USE. THE POLYMERIZATION LAMP SHOULD ONLY BE USED BY TRAINED PROFESSIONALS." _x000D_ _x000D_ _x000D_