Holter System - ANVISA Registration 80991699012
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 80991699012 and manufactured by BTL INDUSTRIES LTD.. The registration is held by BTL BRASIL COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO 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
80991699012
25351473977202215
15789367000103
Company Information
Dates and Status
Nov 21, 2022
VIGENTE
09/18/2025 19:00:01
ECG Analysis System
BTL 8
BTL INDUSTRIES LTD.
80991699026
Apr 07, 2025
Holter System
QUOREONE
QUORETECH BRASIL INDUSTRIA E COMERCIO LTDA
82424409001
Mar 31, 2022
Holter System
Sistema Holter WL
World Life Medical Industria e Comercio Ltda
80884260003
Mar 09, 2015
Holter System
Sistema Holter ECG e ABP
EDAN INSTRUMENTS, INC.
80047309226
Aug 26, 2024
Holter System
Registrador Holter
SHENZHEN CAREWELL ELECTRONICS CO. LTD
80102519334
Jun 02, 2025
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