QOF - BEUDAMED

BIOSTI (Swiss technology of implantology and biomaterials) GmbH

Manufacturer

🇨🇭 Switzerland

Smart Blood Analytics Swiss SA

Manufacturer

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

VIRUS vs. BACTERIA

Device

EU MDR · Eu Md Class 2a ·Smart Blood Analytics Swiss SA·On the market·32 countries

SBAS Software

Device

EU MDR · Eu Md Class 2a ·Smart Blood Analytics Swiss SA·On the market·32 countries

SWISS PHARMA DYNAMIC LTD Zweigniederlassung

Manufacturer

🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Biosensors Europe SA

Manufacturer

🇨🇭 Switzerland·185 Basic UDI-DIs·185 Devices·1 Importer·National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Enforcement

Class II ·Ongoing·Inpeco S.A.·June 10, 2020

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

FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Enforcement

Class II ·Ongoing·Inpeco S.A.·June 10, 2020