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Electrode system for diagnosis and recording of the electrical activity of the brain - Argentina Medical Device Registration

Access comprehensive regulatory information for Electrode system for diagnosis and recording of the electrical activity of the brain in the Argentina medical device market through Pure Global AI's free database. This Registration modification (non-agile) 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 30, 2024.

This page provides complete registration details including product code (1991-37), brand name (DIXI), 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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Registration modification (non-agile) Class III-IV
Electrode system for diagnosis and recording of the electrical activity of the brain
Sistema de electrodos para diagnóstico y registro de la actividad eléctrica del cerebro
Argentina Medical Device Registration
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Product Information

STERILE: Microdeep Deep Electrode: D08-05AM D08-08AM D08-10AM D08-12AM D08-15AM D08-15BM D08-15CM D08-18AM D08-18CM Cortical electrodes: C10-16AIOM C10-08AIOM C10-12BIOM C10-06BIOM C10-16CIOM C10-08CIOM C10-04CIOM Stylus: ACS-770s-10 Screw Guide: ACS-015SMS-10 ACS-020SMS-10 ACS-025SMS-10 ACS-030SMS-10 ACS-035SMS-10 Single-use stereotactic implantation kit: KIP-ACS-510 KIP-ACS-515 KIP-ACS-600 KIP-ACS-605 Guide screw cap: ACS-050S-5 NO STERILES Depth Reporting Device: ACS-751 Sliding ruler: ACS-750 Bone Starter: ACS-745 Guiding instrument: ACS-789/100 ACS-789/120 ACS-1300 ACS-789-PINK Stops: ACS-760 Flat screwdriver for stops: ACS-714 Screwdriver and wrench for guide screw: ACS-710 ACS-711 ACS-715 Dial bar: ACS-740 Connection cables: CBL-05/L CBL-08/L CBL-10/L CBL-12/L CBL-15/L CBL-18/L (L= 45, 120, 150, 180, 300) Microdeep Deep Electrode Thermocoagulation Selector Box: BST-020 Generator interface for selector box for thermocoagulation: BST-103 BST-105 Extension Cable: PCP-18/90 PCP-18/300 Generator Interface Cable: PCP-410 PCP-420

Spanish:

ESTERILES: Electrodo profundo Microdeep: D08-05AM D08-08AM D08-10AM D08-12AM D08-15AM D08-15BM D08-15CM D08-18AM D08-18CM Electrodos corticales: C10-16AIOM C10-08AIOM C10-12BIOM C10-06BIOM C10-16CIOM C10-08CIOM C10-04CIOM Estilete: ACS-770s-10 Guía de tornillo: ACS-015SMS-10 ACS-020SMS-10 ACS-025SMS-10 ACS-030SMS-10 ACS-035SMS-10 Kit de implantación estereoctática de un solo uso: KIP-ACS-510 KIP-ACS-515 KIP-ACS-600 KIP-ACS-605 Tapa de tornillo guía: ACS-050S-5 NO ESTERILES Dispositivo de reporte de profundidad: ACS-751 Regla deslizante: ACS-750 Iniciador de hueso: ACS-745 Instrumento guía: ACS-789/100 ACS-789/120 ACS-1300 ACS-789-ROSA Topes: ACS-760 Destornillador plano para topes: ACS-714 Destornillador y llave para tornillo guía: ACS-710 ACS-711 ACS-715 Barra de marcación: ACS-740 Cables de conexión: CBL-05/L CBL-08/L CBL-10/L CBL-12/L CBL-15/L CBL-18/L (L= 45, 120, 150, 180, 300) Caja de selector para termocoagulacion con electrodo profundo Microdeep: BST-020 Interfaz generador para caja de selector para termocoagulación: BST-103 BST-105 Cable de extensión: PCP-18/90 PCP-18/300 Cable de interfaz generador: PCP-410 PCP-420

Device Classification
Registration Type
Registration modification (non-agile) Class III-IV
Modificación de Registro (no ágil) Clase III-IV
Product Code
1991-37
Brand Name
DIXI
Product Name
Electrode system for diagnosis and recording of the electrical activity of the brain
Sistema de electrodos para diagnóstico y registro de la actividad eléctrica del cerebro
Registration Information
Registration Date
May 30, 2024
Database ID
cmhaytsdn08q7ekuz343yn9bp
Authorized Representative