21 results
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30ms
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Sources: EU EUDAMED, US FDA
Planmed Oy
Manufacturer
🇫🇮 Finland·SGS FIMKO OY
Planmed Oy
Manufacturer
🇫🇮 Finland·4 Basic UDI-DIs·4 Devices·SGS FIMKO OY
Planmed Oy
FDA registration
Planmed Oy·4 products·🇫🇮 Finland
Planmed
FDA UDI
Planmed Oy·06430035430079·Planmed Clarity is a mammographic x-ray unit in...
Planmed
FDA UDI
Planmed Oy·06430035430062·Planmed Verity is a CBCT x-ray scanner for the ...
Planmed
FDA UDI
Planmed Oy·06430035430024·Planmed Nuance Excel is a mammographic x-ray un...
Planmed
FDA UDI
Planmed Oy·06430035430055·Planmed Sophie Classic is a mammographic x-ray ...
Planmed
FDA UDI
Planmed Oy·06430035430130·The Planmed XFI X-ray unit utilizes cone beam c...
VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
Device
EU MDR
·
Eu Md Class 2b
·Planmed Oy·On the market·32 countries
STEREOTACTIC MODULES FOR MAMMOGRAPHY
Device
EU MDD
·
Eu Md Class 2b
·Planmed Oy·No longer on the market·32 countries
DIGITAL MAMMOGRAPHY SYSTEMS
Device
EU MDD
·
Eu Md Class 2b
·Planmed Oy·No longer on the market·32 countries
DIGITAL MAMMOGRAPHY SYSTEMS
Device
EU MDR
·
Eu Md Class 2b
·Planmed Oy·On the market·32 countries
Planmed ClarityGuide
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Planmed Oy·1 device
Planmed Clarity
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Planmed Oy·1 device
Planmed Clarity
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·Planmed Oy·1 device
Planmed Verity
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·Planmed Oy·1 device
Planmed Oy
Importer
🇫🇮 Finland·1 Manufacturer
FI23/0000004
Certificate
MDR QMS·Planmed Oy·SGS FIMKO OY
FI15/07007
Certificate
MDD Annex II (excluding section 4)·Planmed Oy·SGS FIMKO OY·2 Basic UDI-DIs
Image Management Software For Planning Of Otologic And Neurotologic Procedures
FDA classification
FDA Class 2
·Image Management Software For Planning Of Otologic And Neurotologic Procedures