Pure Global

SIEMENS HEALTHCARE S.A - Authorized Company Profile

Explore comprehensive authorized company profile for SIEMENS HEALTHCARE S.A through Pure Global AI's free Argentina medical device database. This company manufactures 450 medical devices registered with ANMAT across 12 registration types. Their registration history spans from Aug 28, 2017 to Aug 14, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 152, IVD Registration Group A and B: 87, Class I-II Registration Modification: 43, 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.

Free Authorized Company Profile
Powered by Pure Global AI
450 Devices
12 Registration Types
SIEMENS HEALTHCARE S.A
Authorized Company
450
Total Devices
12
Registration Types
2017
Earliest
2024
Latest
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Recent Registrations
Latest 20 ANMAT device registrations

1) Atellica IM Intact Parathyroid Hormone (PTH) 2) Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC) 3) Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) 4) Atellica IM Thyroid Uptake (TUp) 5) Atellica IM Calcitonin (CALCT) 6) Atellica IM Calcitonin Master Curve Material (CALCT MCM) 7) Atellica IM TSH3-Ultra II

1074-753

IVD Modification Group A and B
Aug 14, 2024

1) ADVIA Centaur TSH3- ULTRA 2) ADVIA Centaur TSH3- ULTRA II

1074-346

IVD Modification Group A and B
Aug 14, 2024

Controls for Cardiac Marker Immunoassays

Controles para inmunoensayos de Marcadores Cardiacos

1074-884

Registration of products for IVD diagnostics - Group C and D
Aug 13, 2024

Chemiluminescent immunoassays for anti-Rubella IgG or IgM

Inmunoensayos quimioluminiscentes para IgG ó IgM anti-Rubeola

1074-776

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

Quantitative chemiluminescent immunoassay for tumor markers

Inmunoensayo quimioluminiscente cuantitativo para marcadores tumorales

1074-771

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

1) Atellica CH Benzodiazepines (Bnz) 2) Atellica CH Barbiturates (Brb) 3) Atellica CH Methadone (Mdn) 4) Atellica CH Methadone Metabolites (EDDP) (MetMtb) 5) Atellica CH Methadone Metabolite 1000 ng/mL Urine Calibrator (MetMtb CAL) 6) Atellica CH Multi-Drug Urine Controls (MULTIDRUG QC) 7) Atellica CH Opiates (Op) 8) Atellica CH Propoxyphene (Ppx) 9) Atellica CH Oxycodone (OXY)

1074-739

IVD Modification Group A and B
Aug 08, 2024

1. RAPIDQC COMPLETE LEVEL 1 2. RAPIDQC COMPLETE LEVEL 2 3. RAPIDQC COMPLETE LEVEL 3 4. RAPIDQC Hct LEVEL A 5. RAPIDQC Hct LEVEL B 6. CVM Calibration Verification Material 7. HIGH G/L

1074-885

IVD Registration Group A and B
Aug 06, 2024

Quantitative chemiluminescent immunoassays for therapeutic drugs

Inmunoensayos quimioluminiscentes cuantitativos para drogas terapéuticas

1074-781

Non-agile modification of products for IVD diagnostics - Group C and D
Aug 05, 2024

Quantitative chemiluminescent immunoassay for CA 19-9 tumor markers

Inmunoensayo quimioluminiscente cuantitativo para marcadores tumorales CA 19-9

1074-775

Non-agile modification of products for IVD diagnostics - Group C and D
Jul 31, 2024

1) Atellica IM Homocysteine (HCY) 2) Atellica IM Homocysteine Calibrator (HCY CAL) 3) Atellica IM homocysteine diluent (HCY DIL)

1) Atellica IM Homocysteine (HCY) 2) Atellica IM Homocysteine Calibrator (HCY CAL) 3) Atellica IM Homocysteine Diluent (HCY DIL)

1074-779

IVD Modification Group A and B
Jul 30, 2024

Quantitative chemiluminescent immunoassay for procalcitonin

Inmunoensayo quimioluminiscente cuantitativo para procalcitonina

1074-785

Non-agile modification of products for IVD diagnostics - Group C and D
Jul 30, 2024

Chemiluminescent, qualitative and/or quantitative immunoassay, serology, Toxoplasma and CMV

Inmunoensayo quimioluminiscente cualitativo y/o cuantitativo serología Toxoplasma y CMV

1074-777

Non-agile modification of products for IVD diagnostics - Group C and D
Jul 30, 2024

Software/hardware for displaying, processing, transmitting and storing medical images and data in various modalities

Software/hardware para la visualización, el procesamiento, la transmisión y el almacenamiento de imágenes y datos médicos de varias modalidades

1074-815

Revalidation of Registration I-II-III-IV
Jul 24, 2024

1) RAPIDLab 348EX System Accesorios: 2) 6.8/7.3 Buffer 3) Wash and CD Pack 4) Chloride Sensor 5) Calcium Sensor 6) Potassium Sensor 7) Sodium Sensor 8) NA/K/CL Fill Solution 9) pH Sensor Fill Solution (3UDCs) 10) pH Sensor 11) pCO2 Sensor 12) pO2 Sensor 13) Reference Sensor 14) Reference Sensor Inner 15) Reference Fill Solution 16) Hct Sensor 17) Desproteinizer Solution, 18) Conditioner 19) Hct Slope (pack of 10) 20) Gas Cartridge Pack 21) RAPIDLab 348 EX Ca++ Starter Kit, 22) RAPIDLab 348 EX CI- Starter Kit

1) RAPIDLab 348EX System Accesorios: 2) 6.8/7.3 Buffer 3) Wash and CD Pack 4) Chloride Sensor 5) Calcium Sensor 6) Potassium Sensor 7) Sodium Sensor 8) NA/K/CL Fill Solution 9) pH Sensor Fill Solution (3UDCs) 10) pH Sensor 11) pCO2 Sensor 12) pO2 Sensor 13) Reference Sensor 14) Reference Sensor Inner 15) Reference Fill Solution 16) Hct Sensor 17) Desproteinizer Solution, 18) Conditioner 19) Hct Slope (pack of 10) 20) Gas Cartridge Pack 21) RAPIDLab 348 EX Ca++ Starter Kit, 22) RAPIDLab 348 EX CI- Starter Kit

1074-659

IVD Modification Group A and B
Jul 17, 2024

1)ADVIA Centaur T3 2)ADVIA Centaur T3 MCM

1074-343

IVD Modification Group A and B
Jul 11, 2024

Medical image processing software for diagnostic or therapeutic assistance regarding predefined pathologies, using algorithms based on deep learning

software de procesamiento de imágenes médicas para asistencia diagnóstica o terapéutica respecto de patologías predefinidas, utilizando algoritmos basados en aprendizaje profundo

1074-854

Class I-II Registration Modification
Jul 11, 2024

Magnetic Resonance Imaging Scanning Systems.

Sistemas de Exploración de imagen por resonancia magnética.

1074-41

Class I-II Registration Modification
Jul 11, 2024

1. ADVIA Centaur ACCP Assay 2. ADVIA Centaur ACCP Quality Control Material 3. ADVIA Centaur ACCP MCM

1074-855

IVD Modification Group A and B
Jul 08, 2024

Whole Body MRI System

Sistema de Resonancia Magnética para cuerpo entero

1074-801

Class I-II Registration Modification
Jul 05, 2024

Whole Body MRI System

Sistema de Resonancia Magnética para cuerpo entero

1074-691

Class I-II Registration Modification
Jul 05, 2024
Registration Type Distribution
Devices by registration type
IVD Modification Group A and B
152
33.8% of total
IVD Registration Group A and B
87
19.3% of total
Revalidation of Registration I-II-III-IV
47
10.4% of total
Class I-II Registration Modification
43
9.6% of total
Registration modification (non-agile) Class III-IV
30
6.7% of total
Agile modification of product registration for IVD diagnostics - Group C and D
21
4.7% of total
Class I-II Registration
20
4.4% of total
Modification of Agile Registration Class III-IV
19
4.2% of total
Non-agile modification of products for IVD diagnostics - Group C and D
15
3.3% of total
Registration of products for IVD diagnostics - Group C and D
8
1.8% of total
Registration Class III-IV
6
1.3% of total
Revalidation + Modification of Class I-II Registration
2
0.4% of total