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AUTOINYECTOR REBISMART 3.0 / REBISMART 3.0 - INVIMA Registration a140fc53eca4be1e1dc4b7f565e143aa

Access comprehensive regulatory information for AUTOINYECTOR REBISMART 3.0 / REBISMART 3.0 (REBISMART 3.0 / REBISMART 3.0 AUTOINJECTOR) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID a140fc53eca4be1e1dc4b7f565e143aa and manufactured by MERCK S.A.. The device was registered on August 01, 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.

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INVIMA Official Data
IIa
a140fc53eca4be1e1dc4b7f565e143aa
AUTOINYECTOR REBISMART 3.0 / REBISMART 3.0
INVIMA Analysis ID: a140fc53eca4be1e1dc4b7f565e143aa
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Product Use / Uso del Producto
Spanish

REBISMART 3.0 ES UN AUTOINYECTOR ELECTROMECÁNICO NO ESTÉRIL, REUTILIZABLE CONTROLADO POR SOFTWARE DESTINADO A LA INYECCIÓN SUBCUTÁNEA DEL MEDICAMENTO REBIF ® (INTERFERÓN BETA-1A DE MERCK EN PRESENTACIÓN DE CARTUCHO MULTIDOSIS QUE TIENE REGISTRO SANITARIO INDEPENDIENTE AL DISPOSITIVO) EN UN ENTORNO DOMÉSTICO O NO MÉDICO, UTILIZANDO AGUJAS ESTÉRILES DESECHABLES SEROFINE ® (CALIBRE 0.33 X 12MM- 29G X 1/2”) LAS CUALES TAMBIÉN CUENTAN CON REGISTRO SANITARIO INDEPENDIENTE AL DISPOSITIVO. REBISMART ® 3.0 PERMITE REGISTRAR EVENTOS DE DOSIFICACIÓN DE LA MEDICACIÓN Y TRANSFERIR LOS DATOS AUTOMÁTICAMENTE A UNA PLATAFORMA BASADA EN LA NUBE MEDIANTE COMUNICACIÓN MÓVIL CELULAR INTEGRADA._x000D_

English

REBISMART 3.0 IS A NON-STERILE, SOFTWARE-CONTROLLED, REUSABLE ELECTROMECHANICAL AUTO-INJECTOR INTENDED FOR THE SUBCUTANEOUS INJECTION OF THE DRUG REBIF ® (MERCK INTERFERON BETA-1A IN MULTI-DOSE CARTRIDGE FORM THAT HAS A SEPARATE HEALTH REGISTRATION TO THE DEVICE) IN A HOME OR NON-MEDICAL ENVIRONMENT, USING STERILE SEROFINE ® DISPOSABLE NEEDLES (CALIBER 0.33 X 12MM- 29G X 1/2") WHICH ALSO HAVE A SEPARATE HEALTH REGISTRATION TO THE DEVICE. REBISMART ® 3.0 ALLOWS YOU TO RECORD MEDICATION DOSING EVENTS AND AUTOMATICALLY TRANSFER THE DATA TO A CLOUD-BASED PLATFORM USING CELLULAR MOBILE COMMUNICATION INTEGRADA._x000D_

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
a140fc53eca4be1e1dc4b7f565e143aa
Expire Date
August 01, 2033
Authorized Company / Fabricante
Name (Spanish)
MERCK S.A.
Name (English)
MERCK S.A.