Publication of Regulation MDR and IVDR Official Journal of the European Union L117, 5 May 2017 fekdlojoehaaahhg

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UDI book "Unique Device Identification", published in German language by DIN-Beuth-Verlag.

<Link zum Buch>

buch

udilookup 32x32HIBIScan 7.1 may query the US UDI Data Base and displays any found master data.

HIBIScan may be downloaded from the member login at http://www.elmicron.de/login.

udilookup 32x32HIBIScan 8.0 supports HIBC in revision 2.6 containing an optional quantity field at the end of the code with FDA conformity.

HIBIScan may be downloaded at Elmicron under: http://www.elmicron.de/index.php?option=com_visforms&view=visforms&id=3&Itemid=546.

udilookup 32x32Using HIBIScan 8.2, a Datamatrix code symbol may be created and saved.

 

News in this version:

  • code resolution may be chosen in the options menu.
  • code symbol may be copied to clipboard for easy usage in a graphic program

HIBIScan may be downloaded at Elmicron under: https://elmicron.de/download/hibiscan.html.

hibiscan 32x32HIBIScan 6.4 additionaly supports extended HIBC codes with a quantity and a serial number field. This is provided by the current HIBC provider standard revision 2.5.

Those codes feature a secondary code part like "/$$812/SSER123" or "/$$912345/SSER123".

The download is available at http://www.elmicron.de/

HIBIScan allows to check and generate HIBC codes. The included batch wizard allows to create a set of codes in one run.

Next step of the UDI-registration wave: Beginning February 1, 2016, FDA will accept GUDID account requests from labelers of US class II devices. Manufacturers will be in the position to register this class of products after the personal account has been set up by FDA and acknowledged. The first step was to open the registration for class III devices.

HIBC UDI Emblem DMTRX 140206b

150505-LS kleinUDI presentation from Laurent Selles, European Commission DG for Internal Market, Industry, Entrepreneurship and SMEs Unit D4 – Health Technology & Cosmetics available as video.  >> click here