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REGULATORY DOCUMENTS
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INTERVENTIONAL CARDIOLOGY
DES B.E. – Cre8™ BTK
IFU
Rev. 4 (Revision date is 06.2017)
Rev. 5 (Revision date is 04.2023)
CE
CE Cre8 BTK
Extension Letter-EU 2023-603
DoC
DoC Cre8 BTK
BMS B.E. – Radix2
IFU
Rev. 4 (Revision date is 11.2020)
Rev. 5 (Revision date is 06.2022)
CE
CE Radix 2
Extension Letter-EU 2023-603
DoC
DoC_Radix2
BMS B.E. – Isthmus Logic
IFU
Issued Rev. 6 (Revision date is 06.2019)
Issued Rev. 7 (Revision date is 04.2022)
CE
CE Isthmus Logic
Extension Letter-EU 2023-603
DoC
DoC Istmus Logic
BMS S.E. – Easy HiFlype
IFU
Rev. 6 (Revision date is 09.2019)
Rev. 7 (Revision date is 05.2021)
Rev. 8 (Revision date is 06.2022)
CE
CE Easy Flype
Extension Letter-EU 2023-603
DoC
DoC Easy Flype
BMS S.E. – Easy Flype
IFU
Rev. 6 (Revision date is 09.2019)
Rev. 7 (Revision date is 05.2021)
Rev. 8 (Revision date is 06.2022)
CE
CE Easy Flype
Extension Letter-EU 2023-603
DoC
DoC Easy Flype
DES S.E. - NiTiDES™
IFU
Issued Rev. 0 (Revision date is 05.2021)
CE
CE Nitides
Extension Letter-EU 2023-603
DoC
DoC Nitides
BMS B.E.-Inperia Advance
IFU
Rev. 5 (Revision date is 01.2020)
CE
CE Inperia Advance
Extension Letter-EU 2023-603
DoC
DoC Inperia Advance
