19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: France
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DIM FRANCE
Manufacturer
🇫🇷 France
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
FDA Enforcement
Class II
·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014
GAMIDA TECH
Manufacturer
🇫🇷 France·4 Basic UDI-DIs·4 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Enforcement
Class II
·Terminated·Maquet SAS·June 6, 2018
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Enforcement
Class II
·Terminated·Maquet SAS·July 25, 2018
AdiMate®
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Neosyad SAS·1 device
Kaio-Dia
Importer
🇫🇷 France·1 Manufacturer
Roue du Dr Aimé
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·NEWMEDI·1 device
Aiming device for ACL reconstruction
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·S.B.M. SAS·2 devices
Bio-Rad
Authorized representative
🇫🇷 France·6 Manufacturers
FIM Médical
System producer
🇫🇷 France
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
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
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