8 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: France
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Thérapie digitale JOE
Basic UDI-DI
EU MDR
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Eu Md Class 1
·LUDOCARE·1 device
LEE COOPER FRANCE
Importer
🇫🇷 France
MAST DIAGNOSTIC
Importer
🇫🇷 France·3 Manufacturers
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
FDA Enforcement
Class II
·Terminated·Imactis·March 24, 2021
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
FDA Enforcement
Class III
·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
FDA Enforcement
Class II
·Terminated·EOS Imaging·July 5, 2017
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.
FDA Enforcement
Class II
·Ongoing·Medicrea International·February 12, 2025
VYTIL
Importer
🇫🇷 France·30 Manufacturers