Holter System - ANVISA Registration 80288099012
Access comprehensive regulatory information for Holter System in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80288099012 and manufactured by MORTARA INSTRUMENT, INC. The registration is held by TKL IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 companies making the same product including CARDIO SISTEMAS COMERCIAL E INDUSTRIAL LTDA, MICROMED BIOTECNOLOGIA S.A., and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
80288099012
25351261757201353
07415627000152
Company Information
Dates and Status
Apr 07, 2014
VIGENTE
09/18/2025 19:00:01
CARDIO SISTEMAS COMERCIAL E INDUSTRIAL LTDA• Brazil
MICROMED BIOTECNOLOGIA S.A.• Brazil
SUZHOU BENEWARE MEDICAL EQUIPMENT CO., LTD• China
DIAGNOSTIC MONIT. SOFTWARE• United States of America
SHENZHEN CAREWELL ELECTRONICS CO. LTD• China
Sistema Holter
Registrador Holter
SHENZHEN CAREWELL ELECTRONICS CO. LTD
80102519334
Jun 02, 2025
Sistema Holter
Gravador Holter Digital
SHD HOLTER DIGITAL
81131629002
Aug 26, 2024
Sistema Holter
Cardioline Walk Free
LIVETEC INGENIEURBÜRO GMBH
81464759045
Aug 26, 2024
Sistema Holter
Sistema Holter ECG e ABP
EDAN INSTRUMENTS, INC.
80047309226
Aug 26, 2024
Sistema Holter
Sistemas Holter CardioTrak Digital
SUZHOU BENEWARE MEDICAL EQUIPMENT CO., LTD
81464759042
Mar 25, 2024

