2,090 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OSTEOTRANS
Device
EU MDD
·
Eu Md Class 3
·TEIJIN MEDICAL TECHNOLOGIES CO., LTD.·On the market·4 countries
Bioptimal Thermodilution Catheter and Kits
Device
EU MDD
·
Eu Md Class 3
·Bioptimal International PTE. LTD.·On the market·11 countries
Cera
Device
EU MDD
·
Eu Md Class 3
·LifeTech Scientific (Europe) B.V.·On the market·32 countries
Sofwave Medical Ltd.
Manufacturer
🇮🇱 Israel·1 Basic UDI-DI·1 Device·1 Importer·DEKRA Certification B.V.
Thermodilution Catherter and Kits
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Bioptimal International PTE. LTD.·1 device
OSTEOTRANS-OT
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·TEIJIN MEDICAL TECHNOLOGIES CO., LTD.·1 device
Sofwave
Device
EU MDD
·
Eu Md Class 2a
·Sofwave Medical Ltd.·On the market·6 countries
Aziyo Biologics, Inc.
Manufacturer
🇺🇸 United States·11 Basic UDI-DIs·11 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.
LGC Clinical Diagnostics, Inc.
Manufacturer
🇺🇸 United States·133 Basic UDI-DIs·133 Devices·DEKRA Certification B.V.
IBSA Pharma SAS
Manufacturer
🇫🇷 France·3 Basic UDI-DIs·3 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.
Aroa Biosurgery Ltd.
Manufacturer
🇳🇿 New Zealand·69 Basic UDI-DIs·69 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.
IOPtima Ltd.
Manufacturer
🇮🇱 Israel·1 Basic UDI-DI·1 Device·1 Importer·DEKRA Certification B.V.
CathWorks Ltd.
Manufacturer
🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·1 Importer·DEKRA Certification B.V.
Henan Simedice Biotechnologies Co.,Ltd.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·1 Importer·DEKRA Certification B.V. and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Augma Biomaterials
Manufacturer
🇮🇱 Israel·6 Basic UDI-DIs·6 Devices·13 Importers·DEKRA Certification B.V. and DEKRA Certification B.V.
NP Medical, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·DEKRA Certification B.V.
Sofwave
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Sofwave Medical Ltd.·1 device
3902551CE01
Certificate
MDD Annex II (excluding section 4)·Sofwave Medical Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI
iMDsoft Ltd
Manufacturer
🇮🇱 Israel·1 Basic UDI-DI·1 Device·1 Importer·DEKRA Certification B.V.
TauroPharm GmbH
Manufacturer
🇩🇪 Germany·9 Basic UDI-DIs·9 Devices·DEKRA Certification B.V., DEKRA Certification B.V., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH