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    SCANDERRA LLB AG

    FDA registration
    SCANDERRA LLB AG·7 products·🇨🇭 Switzerland

    Straumann BLX Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Straumann BLX Variobase Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Straumann BLX Surgical Cassette

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Straumann BLX Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Straumann BLX Ø3.5 mm Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    Smartcanula LLC

    Manufacturer
    🇨🇭 Switzerland·3 Importers

    Straumann BLX Line Extension - New Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA

    FDA 510(k)
    FDA Class 2 ·Dental

    Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    AVA Sciences-FMTC LLC

    Manufacturer
    🇨🇭 Switzerland

    BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    Smart Blood Analytics Swiss SA

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020

    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    FlexLab (FLX); Version: FLX-217-10;

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·December 3, 2025

    FlexLab (FLX); Version: FLX-217-40;

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·December 3, 2025

    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·June 3, 2020