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Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser - Argentina Medical Device Registration

Access comprehensive regulatory information for Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser in the Argentina medical device market through Pure Global AI's free database. This IVD Modification Group A and B medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on June 12, 2024.

This page provides complete registration details including product code (1716-199), brand name (Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser), 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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Argentina ANMAT Data
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IVD Modification Group A and B
Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Analizadores marca Mindray: 1)Sistema de procesamiento de muestras modelo: NEW CAL 8000; Compuesto por el analizador hematol贸gico automatizado modelo BC-6800Plus y/o el analizador automatizado de prote铆na C reactiva modelo CRP-M100 (incluyendo accesorios: LIMPIADOR CRP) 2)Analizador hematol贸gico automatizado; Modelo: BC-5310 CRP Consumibles: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Argentina Medical Device Registration
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NEW CAL 8000 (BC-6800Plus; CRP-M100) BC-5310 CRP

Device Classification
Registration Type
IVD Modification Group A and B
Modificaci贸n IVD Grupo A y B
Product Code
1716-199
Brand Name
Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Analizadores marca Mindray: 1)Sistema de procesamiento de muestras modelo: NEW CAL 8000; Compuesto por el analizador hematol贸gico automatizado modelo BC-6800Plus y/o el analizador automatizado de prote铆na C reactiva modelo CRP-M100 (incluyendo accesorios: LIMPIADOR CRP) 2)Analizador hematol贸gico automatizado; Modelo: BC-5310 CRP Consumibles: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Product Name
Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Analizadores marca Mindray: 1)Sistema de procesamiento de muestras modelo: NEW CAL 8000; Compuesto por el analizador hematol贸gico automatizado modelo BC-6800Plus y/o el analizador automatizado de prote铆na C reactiva modelo CRP-M100 (incluyendo accesorios: LIMPIADOR CRP) 2)Analizador hematol贸gico automatizado; Modelo: BC-5310 CRP Consumibles: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser
Registration Information
Registration Date
June 12, 2024
Database ID
cmhayu5bi0kthekuzo7ky57sg
Documents
Authorized Representative