13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
FDA Enforcement
Class III
·Terminated·Technidata S.A.·April 9, 2014
Stir bars
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·SD Innovation·1 device
DUAD-BAR-AC
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACIME FRAME·2 devices
SKOT-BAR-AC
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACIME FRAME·1 device
MANC-BAR-AC
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACIME FRAME·1 device
MANC-BAR-NI
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACIME FRAME·1 device
Glass tubes + Stir bars
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·SD Innovation·1 device
Argon Medical Cryochirurgical 300 bar
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Messer France·5 devices
Argon médical chirurgical 200 bar
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Messer France·1 device
Argon Médical chirurgical 200 bar
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Messer France·1 device
IT267632 - 1
Certificate
MDD Annex II (excluding section 4)·DIS PAR·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI
Remedee wristband OA
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Remedee Labs SA·2 devices
OKO SOLUTION
Importer
🇫🇷 France·11 Manufacturers