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ROCHE S.A. PRODUCTS - Authorized Company ProfilePRODUCTOS ROCHE S.A.

Explore comprehensive authorized company profile for ROCHE S.A. PRODUCTS through Pure Global AI's free Argentina medical device database. This company manufactures 660 medical devices registered with ANMAT across 11 registration types. Their registration history spans from Apr 04, 2018 to Aug 14, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Registration Group A and B: 156, IVD Modification Group A and B: 333, Agile modification of product registration for IVD diagnostics - Group C and D: 57, and more), and complete regulatory information from the official Argentina ANMAT (National Administration of Drugs, Foods and Medical Technology) medical device database with bilingual Spanish/English support. Pure Global AI offers free access to Argentina's complete medical device registry.

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660 Devices
11 Registration Types
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.
Authorized Company
660
Total Devices
11
Registration Types
2018
Earliest
2024
Latest
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Recent Registrations
Latest 20 ANMAT device registrations

Immunological test for the quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma.

Test inmunológico para la determinación cuantitativa de la gonadotropina coriónica humana (hCG) en suero y plasma humanos.

740-8544

Non-agile modification of products for IVD diagnostics - Group C and D
Aug 14, 2024

Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma.

Inmunoensayo de electroquimioluminiscencia ”ECLIA” destinado a la detección cuantitativa del antígeno prostático específico total (tPSA) en suero y plasma humanos.

740-738

Non-agile modification of products for IVD diagnostics - Group C and D
Aug 09, 2024

Electrochemiluminescence immunoassay "ECLIA" for the quantitative determination of a1-fetoprotein in human serum and plasma.

Inmunoensayo de Electroquimioluminiscencia "ECLIA" para la determinación cuantitativa de la a1-fetoproteína en suero y plasma humanos.

740-8563

Agile modification of product registration for IVD diagnostics - Group C and D
Aug 08, 2024

An algorithm that can be used in conjunction with other diagnostic methods to detect hepatocellular carcinoma.

Algoritmo que puede utilizarse junto con otros métodos de diagnóstico para detectar el carcinoma hepatocelular.

740-833

Non-agile modification of products for IVD diagnostics - Group C and D
Aug 08, 2024

System for Continuous Subcutaneous Insulin Infusion.

Sistema para la Infusión Subcutánea Continua de Insulina.

740-886

Registration Class III-IV
Aug 05, 2024

1- cobas pro Transport Belt (2 AU, 2 ISE) 2- cobas pro Transport Belt (3 AU, 2 ISE) 3- cobas pro Transport Belt (4 AU, 2 ISE) 4- cobas pro SSU 5- cobas pro SB 6- cobas pro transport line 7- cobas pro SBL c 503 8- cobas pro SBL e 801 9- cobas c 703 analytical unit 10- cobas ISE neo 1800 analytical unit 11- cobas ISE neo 900 analytical unit 12- cobas pro SBL c 703 13- Reaction Cell for c 703 14- Alarm Tower Kit 15- cobas c 503 decoupling kit 16- ISE Internal Standard Gen.2 conc. 17- 3000m Liq.Fl.Path Mod.kit e801

740-784

IVD Modification Group A and B
Jul 30, 2024

Accu-Chek Performa Glucose Monitoring System

Sistema de monitoreo de glucosa Accu-Chek Performa

740-880

Registration of products for IVD diagnostics - Group C and D
Jul 24, 2024

1- Cobas SARS-COV-2 – 192T 2- Cobas SARS-COV-2 – 480T 3-2 Control Kit 4- Cobas SARS-COV-2 Qualitative 192T 5- Cobas SARS-COV-2 Qualitative 480T 6- Coach SARS-COV-2 Control Qualitative Kit

1- cobas SARS-COV-2 – 192T 2- cobas SARS-COV-2 – 480T 3- cobas SARS-COV-2 Control Kit 4- cobas SARS-COV-2 Qualitative 192T 5- cobas SARS-COV-2 Qualitative 480T 6- cobas SARS-COV-2 Control Qualitative Kit

740-800

IVD Modification Group A and B
Jul 17, 2024

1- cobas SARS-COV-2 Nucleic acid test for use on the cobas Liat System 2- cobas SARS-COV-2 Quality Control Kit for use on the cobas Liat System

740-813

IVD Modification Group A and B
Jul 17, 2024

Elecsys HTLV-I/II

740-590

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 17, 2024

1) CC 25mM 2) Owren B 3) Day Clean 4) CleanSol 5) Imid Buff 6) Kaolin

740-453

IVD Modification Group A and B
Jul 16, 2024

Immunoassays for the quantitative determination of CA 72-4 in human serum and plasma.

Inmunoensayos para la determinación cuantitativa del CA 72-4 en suero y plasma humanos.

740-3905

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 15, 2024

Immunoassay for the qualitative determination of hepatitis B surface antigen (HBsAg).

Inmunoensayo para la determinación cualitativa del antígeno de superficie de la hepatitis B (HBsAg).

740-588

Non-agile modification of products for IVD diagnostics - Group C and D
Jul 15, 2024

In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma.

Inmunoensayo in vitro para la determinación cuantitativa del antígeno CA 15-3 en suero y plasma humanos .

740-554

Non-agile modification of products for IVD diagnostics - Group C and D
Jul 15, 2024

ACCU-CHEK Active Glucose Monitoring System

Sistema de monitoreo de glucosa ACCU-CHEK Active

740-879

Registration of products for IVD diagnostics - Group C and D
Jul 05, 2024

cobas e 402 analytical unit.

740-783

IVD Modification Group A and B
Jul 01, 2024

1- Elecsys PTH 2- CalSet PTH 3- Elecsys PTH (1-84) 4- CalSet II PTH

740-851

IVD Modification Group A and B
Jun 25, 2024

Assays for different coagulation tests on cobas t 511/711 and cobas t 411 analyzers

Ensayos destinados a diferentes pruebas de coagulación en los analizaodres cobas t 511/711 y cobas t 411

740-859

Non-agile modification of products for IVD diagnostics - Group C and D
Jun 13, 2024

ACCU-CHECK Guide Glucose Monitoring System

Sistema de monitoreo de glucosa ACCU-CHECK Guide

740-881

Registration of products for IVD diagnostics - Group C and D
Jun 07, 2024

1- AssayTip/AssayCup 2- AssayTip 3- AssayTip/AssayCup Tray 4- AssayCup

740-727

IVD Modification Group A and B
Jun 06, 2024
Registration Type Distribution
Devices by registration type
IVD Modification Group A and B
333
50.5% of total
IVD Registration Group A and B
156
23.6% of total
Non-agile modification of products for IVD diagnostics - Group C and D
65
9.8% of total
Agile modification of product registration for IVD diagnostics - Group C and D
57
8.6% of total
Registration of products for IVD diagnostics - Group C and D
35
5.3% of total
Class I-II Registration
7
1.1% of total
Class I-II Registration Modification
3
0.5% of total
Class I-II Registration Revalidation
1
0.2% of total
Revalidation + Modification of Class I-II Registration
1
0.2% of total
Revalidation of Registration I-II-III-IV
1
0.2% of total
Registration Class III-IV
1
0.2% of total