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 similar products found using AI-powered semantic search, 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.

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Registration Details
80288099012
25351261757201353
07415627000152
Company Information
Dates and Status
Apr 07, 2014
VIGENTE
09/18/2025 19:00:01
Holter System
Gravador Holter Digital
SHD HOLTER DIGITAL
81131629002
Aug 26, 2024
Holter Analysis System
GRAVADOR DE HOLTER
PRO LIFE EQUIPAMENTOS MÉDICOS LTDA
10394539003
Feb 03, 2020
Holter Analysis System
GRAVADOR DE HOLTER
Pró-Life Equipamentos médicos ltda
82776289002
Dec 09, 2024
Holter System
GRAVADOR DIGITAL DE HOLTER CARDIOLIGHT
CARDIO SISTEMAS COMERCIAL E INDUSTRIAL LTDA
10361050006
May 19, 2005
Holter System
Gravador de Holter Ambulatorial
MICROMED BIOTECNOLOGIA S.A.
10307270009
Mar 30, 2015
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