19 results · 20ms · Sources: EU EUDAMED, US FDA

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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