406 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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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
GAMIDA TECH
Manufacturer
🇫🇷 France·4 Basic UDI-DIs·4 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Kaio-Dia
Importer
🇫🇷 France·1 Manufacturer
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
IT267632 - 1
Certificate
MDD Annex II (excluding section 4)·DIS PAR·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI
Kaio-Dia
Authorized representative
🇫🇷 France·1 Manufacturer·2023 Devices
MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES
Device
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·No longer on the market·10 countries
MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES
Device
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·On the market·11 countries
MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT
Device
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·On the market·8 countries
CE 663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
Set SunChip1 ouvert
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·1 device
Set SunChip 2
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·1 device
SunChip2
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GAMIDA TECH·1 device
FibroMax
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Biopredictive·1 device
1850/MDD
Certificate
MDD Annex II (excluding section 4)·GAMIDA TECH·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·3 Basic UDI-DIs