Regulatory Open Forum

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  • 1.  Manufacturing site MDL#

    Posted 10-Jul-2012 09:04

    Anybody has an idea where to look for information on Manufacturing site MDL# for a product/device or what that means?

    I am having problems providing this request for a supplier.

  • 2.  RE:Manufacturing site MDL#

    Posted 10-Jul-2012 09:38
    It may refer to Medical Device Listing ("MDL") number.

    You search for it at 

    In Canada, you search for it at 

    United States

  • 3.  RE:Manufacturing site MDL#

    Posted 10-Jul-2012 10:24

    That was exactly what I thought. The FDA site has two numbers Registered Establishment Number and owner/operator number but it does not specifically state a MDL#. I am nit sure if the Registered Establishment number is the same as the MDL#.

  • 4.  RE:Manufacturing site MDL#

    Posted 10-Jul-2012 10:46
    For example, please see below.

    Registration Listing ID ' Registration Key ' File ID


    United States

  • 5.  RE:Manufacturing site MDL#

    Posted 10-Jul-2012 11:00

    Thank you for the follow up. I was given an example as starting with a letter e.g. MDL no. D042584

  • 6.  RE:Manufacturing site MDL#

    Posted 11-Jul-2012 07:40
    That example is definately a medical device listing number - though from the old paper forms (which used to have an Axxxxxx, Bxxxxx set of forms)- the format may be different now that the listing is all electronic, but that is what the request is for. If request is from a supplier, they may be looking for the information to include it on shipping paperwork.

    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    American Medical Systems Inc
    Minnetonka MN
    United States

  • 7.  RE:Manufacturing site MDL#

    Posted 11-Jul-2012 14:26
    The MDL number is assigned to each product listing under your FDA registration. Your official FDA correspondent should be able to access the FDA FURLS account and call up the listings associated with your specific product. As part of the listing, FDA wil have a number listed.

    BTW, I was confuse by this the first time I encountered it, too!

    Mark Loewen
    Director, QA/RA
    First Quality Hygienic, Inc.
    McElhattan PA
    United States

  • 8.  RE:Manufacturing site MDL#

    Posted 11-Jul-2012 12:47
    The MDL# is the medical device listing number issued for the device via CDRH FDA Industry Systems. You would need to contact your supplier for this number. They are not found on any website as they are proprietary information.

    Martha Guzman
    RA/QA Manager
    United States