25 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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A-CP-Kit-4
Device
EU MDD
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Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-3
Device
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-2
Device
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-1
Device
EU MDD
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Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-T
Device
EU MDD
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Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-3 (20ml)
Device
EU MDD
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Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-T (20ml)
Device
EU MDD
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Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-2 Plus
Device
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
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
A-CP-Kit-4
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-3
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-2
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-1
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-T
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-2 Plus
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-3 (20ml)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-T (20ml)
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·1 device
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), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 16, 2018
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 20, 2021