ANVISA registration 80224390321Valid until Apr 13, 2036SINGLE CHAMBER IMPLANTABLE CARDIAC PACEMAKER, WITH RATE RESPONSE
ANVISA Registration Number: 80224390321BIOTRONIK COMERCIAL MÉDICA LTDA.BIOTRONIK SE & CO KGRisk Class IV
Device names
- Technical name
- SINGLE CHAMBER IMPLANTABLE CARDIAC PACEMAKER, WITH RATE RESPONSE
- Commercial name
- ENTICOS - MARCAPASSO CARDÍACO IMPLANTÁVEL DE CÂMARA ÚNICA COM RESPOSTA DE FREQUÊNCIA, CONDICIONAL PARA RESSONÂNCIA MAGNÉTICA (FULLBODY)
- Risk class
- Class IV
PT: MARCA-PASSO CARDÍACO IMPLANTÁVEL DE CÂMARA ÚNICA, COM RESPOSTA DE FREQUÊNCIA
Registration details
- Registration Number
- 80224390321
- Process Number
- 25351026361202674
- CNPJ
- 50595271000105
Company information
- Registration Holder
- BIOTRONIK COMERCIAL MÉDICA LTDA.
- Manufacturer
- BIOTRONIK SE & CO KG
- Manufacturing Country
- Germany
PT: ALEMANHA
Dates and status
- Publication Date
- Apr 13, 2026
- Validity
- 13/04/2036
- Last Updated
- 08/18/2026 19:00:00
About this record
Access comprehensive regulatory information for SINGLE CHAMBER IMPLANTABLE CARDIAC PACEMAKER, WITH RATE RESPONSE in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80224390321 and manufactured by BIOTRONIK SE & CO KG. The registration is held by BIOTRONIK COMERCIAL MÉDICA LTDA. with validity until Apr 13, 2036.
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