35 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
×
A-CP-Kit-4
Device
EU MDD
·
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
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-T
Device
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-3 (20ml)
Device
EU MDD
·
Eu Md Class 2b
·Regen Lab SA·On the market·32 countries
A-CP-Kit-T (20ml)
Device
EU MDD
·
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
Rontis Corporation SA
Manufacturer
🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o
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
·
Eu Md Class 2b
·Regen Lab SA·1 device
A-CP-Kit-3
Basic UDI-DI
EU MDD
·
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