Argentina flag961-232

Heart Failure Monitoring System.

Sistema de Monitoreo de Falla Cardíaca.

Argentina Medical Device Registration · St. Jude Medical; Abbott · ST. JUDE MEDICAL ARGENTINA S.A. · Registered May 27, 2024

Modification of Agile Registration Class III-IV
Device classification
Registration Type
Modification of Agile Registration Class III-IV
Modificación de Registro Ágil Clase III-IV
Product Code
961-232
Brand Name
St. Jude Medical; Abbott
Product Name
Heart Failure Monitoring System.
Sistema de Monitoreo de Falla Cardíaca.
Registration information
Registration Date
May 27, 2024
Database ID
cmhayu7b50lvsekuze3sew2nd
Authorized representative
Documents
Product information

CardioMEMS HF System, consisting of: CM3000- CardioMEMS Hospital Electronic System. (Manufacturer 1 & 2) CM1100- CardioMEMS 13 Electronic Patient System. (Manufacturer 1 and 2). CM1000- CardioMEMS Electronic Patient System (GSM). (Manufacturer 2); CM1010- CardioMEMS Electronic Patient System (Landline) (Manufacturer 2); CM2000 CardioMEMS AP Sensor with Placement Catheter (Manufacturer 2); Accessories (Manufacturer 2): CM1020-CardioMEMS Remote Button; CM1030- CardioMEMS Pillow; CM1040 GSM Antenna; CM1050 Orientation Ball; CM1060 CardioMEMS Travel Case; CM111 0-i3 Power Source; CM1120-i3 Travel Case; CM1130 Portable CardioMEMS; CM301 or CardioMEMS printer; CM3011 CardioMEMS Printer Cables; CM3012 CardioMEMS Printer Power Cables; CM3013 printer paper. CM3020 11 O V Power Cable; CM3021 220V Power Cable; CM3022 Power Cable; CM3023 220V Power Cable; CM3040 Wi-fi Adapter.

Spanish:

Sistema CardioMEMS HF, compuesto por: CM3000- CardioMEMS Sistema Electrónico de Hospital. (Fabricante 1y 2) CM1100- CardioMEMS 13 Sistema Electrónico del Paciente. (Fabricante 1 y 2). CM1000- CardioMEMS Sistema Electrónico del Paciente (GSM). (Fabricante 2); CM1010- CardioMEMS Sistema Electrónico del Paciente (Línea terrestre) (Fabricante 2); CM2000 CardioMEMS Sensor AP con catéter de colocación (Fabricante 2); Accesorios (Fabricante 2): CM1020-CardioMEMS Botón remoto; CM1030- CardioMEMS Almohada; CM1040 Antena GSM; CM1050 Bolita de orientación; CM1060 CardioMEMS Estuche de viaje; CM111 0-i3 Fuente de energía; CM1120-i3 Estuche de viaje; CM1130 CardioMEMS Portátil; CM301 O CardioMEMS Impresora; CM3011 CardioMEMS Cables de impresora; CM3012 CardioMEMS Cables de energía de impresora; CM3013 papel de impresora. CM3020 Cable de energía de 11 O V; CM3021 Cable de energía de 220 V; CM3022 Cable de energía; CM3023 Cable de energía de 220 V; CM3040 Adaptador Wi-fi.

About this record

Access comprehensive regulatory information for Heart Failure Monitoring System. in the Argentina medical device market through Pure Global AI's free database. This Modification of Agile Registration Class III-IV medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on May 27, 2024.

This page provides complete registration details including product code (961-232), brand name (St. Jude Medical; Abbott), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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