396 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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PITStop® implant
FDA 510(k)
FDA Class 2
·Orthopedic
BIT Group France
FDA registration
BIT Group France·1 product·🇫🇷 France
BIT Group France
FDA registration
BIT Group France·1 product·🇫🇷 France
HEAD IMPACTOR BIT
Device
EU MDR
·
Eu Md Class 1
·groupe lépine·On the market
HEAD IMPACTOR BIT
Device
EU MDR
·
Eu Md Class 1
·groupe lépine·On the market
Kurage SAS
Authorized representative
🇫🇷 France·1 Manufacturer·4 Devices
Orthopaedic implant drill bits, single use
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·groupe lépine·4 devices
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·NEOSTEO·August 18, 2021
MODEL SYSTEMS & KITS
Importer
🇫🇷 France
FibroMax
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Biopredictive·1 device
DECOCENT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGNOTIS SAS·1 device
MYCOPROSAFE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGNOTIS SAS·1 device
MYCOPROSAFE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGNOTIS SAS·1 device
MYCOPROSAFE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGNOTIS SAS·1 device
MYCOPROSAFE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGNOTIS SAS·1 device
SirYus InTest
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Innobiochips·1 device
HYDRASYS CONTAINER KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·sebia·1 device
A1C/CE LOW VOLUME SAMPLE COLLECTION TUBE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·sebia·1 device
TEST TUBES (200)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·sebia·1 device
A1C/CE - CAPILLARY BLOOD SAMPLE KIT (A)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·sebia·1 device