Argentina flag1077-85

Transcutaneous pCO2, SpO2 and pulse rate monitor

Monitor transcutáneo de pCO2, SpO2 y frecuencia de pulso

Argentina Medical Device Registration · SenTec · MEDIX MEDICAL DEVICES S.R.L. · Registered August 07, 2024

Revalidation of Registration I-II-III-IV
Device classification
Registration Type
Revalidation of Registration I-II-III-IV
Reválida de Registro I-II-III-IV
Product Code
1077-85
Brand Name
SenTec
Product Name
Transcutaneous pCO2, SpO2 and pulse rate monitor
Monitor transcutáneo de pCO2, SpO2 y frecuencia de pulso
Registration information
Registration Date
August 07, 2024
Database ID
cmhaytq4b079qekuzfnc3jsxp
Authorized representative
Documents
Product information

Manufacturer 1: SenTec Digital Monitor (SDM) V-Sign 2 Sensor (VS-A/P/N) OxiVenT SENSOR (OV-A/P/N) V-STATS (V-STATS_CD) 150cm Extension Cord (AC-150) 250cm Extension Cord (AC-250) 750cm Extension Cord (AC-750) Membrane Changer (Rechargeable) (MC-R) Membrane Changer Insert (MC-I) Gas Service (GAS-0812) Contact Gel [5ml] (GEL 04) Single-dose contact gel (GEL-SD) SDM Water Protection Cover (SDM_WPC) Membrane Changer (Single Use) (MC) Manufacturer 1 & 2: Ear Clip (EC-MI) Multi-site fixing ring MAR-MI (MAR-MI) Multi-site fixing ring MAR-SF (MAR-SF) MARe-MI Multi-Site Attachment Ring (MARe-MI) MARe-SF Multi-Site Attachment Ring (MARe-SF) Staysite Adhesive (SA-MAR)

Spanish:

Fabricante 1: Monitor digital SenTec (SDM) Sensor V-Sign 2 ( VS-A/P/N) Sensor OxiVenT (OV-A/P/N) V-STATS (V-STATS_CD) Cable de extensión de 150 cm (AC-150) Cable de extensión de 250 cm (AC-250) Cable de extensión de 750 cm (AC-750) Cambiador de membrana (recargable) (MC-R) Inserto de cambiador de membrana (MC-I) Gas de servicio (GAS-0812) Gel de contacto [5ml] (GEL 04) Gel de contacto monodosis (GEL-SD) Funda de protección contra el agua SDM (SDM_WPC) Cambiador de membrana (de un sólo uso) (MC) Fabricante 1 y 2: Clip para oreja (EC-MI) Anillo de fijación multisitio MAR-MI (MAR-MI) Anillo de fijación multisitio MAR-SF (MAR-SF) Anillo de fijación multisitio MARe-MI (MARe-MI) Anillo de fijación multisitio MARe-SF (MARe-SF) Adhesivo Staysite (SA-MAR)

About this record

Access comprehensive regulatory information for Transcutaneous pCO2, SpO2 and pulse rate monitor in the Argentina medical device market through Pure Global AI's free database. This Revalidation of Registration I-II-III-IV medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on August 07, 2024.

This page provides complete registration details including product code (1077-85), brand name (SenTec), 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.

Free DatabasePowered by Pure Global AIArgentina ANMAT DataBilingual (Spanish/English)