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Reference

The Rules Behind a Medical Equipment Catalog

Identifiers, registrations, claim limits and product data requirements, explained for the people who have to put them into a catalog. Every regulatory statement on these pages is traced to the document it came from, and none of it is legal advice.

All Reference Pages

Start With the Question You Have

  • Device identification

    UDI and GUDID Data Requirements for Catalog Teams

    A unique device identifier is not one number. It is a fixed part and a variable part, and confusing them is what turns a clean catalog into a pile of near duplicate records.

    Reviewed August 27, 2026 · 6 min read · 5 sources

    At a Glance

    Who the obligation falls on
    The labeler, meaning whoever puts the label on the device or causes it to be replaced
    What is submitted to the GUDID
    The device identifier and the record attributes that go with it
    Read the reference
  • Device identification

    EUDAMED Registration Deadlines and What They Require

    Two dates, two different populations of device, and one obligation that catches distributors even though distributors do not register.

    Reviewed August 27, 2026 · 4 min read · 4 sources

    At a Glance

    Mandatory from
    28 May 2026, for actor registration and for devices placed on the market on or after that date
    Legacy device deadline
    28 November 2026, for devices placed on the EU market before 28 May 2026
    Read the reference
  • Product information

    The Product Data a Medical Device Catalog Actually Needs

    Most catalogs fail not because a field is missing but because three kinds of fact were stored in one place, so nothing can be trusted at the level it is used.

    Reviewed August 27, 2026 · 5 min read · 3 sources

    At a Glance

    Layer 1, identity
    Manufacturer, model or reference, device identifier, GTIN, nomenclature code
    Layer 2, device facts
    Specifications and characteristics true of every unit of the model
    Read the reference
  • Claim review

    What a Medical Device Listing Can and Cannot Claim

    The riskiest sentence in a product listing is rarely the one somebody made up. It is the one that was true about a different device.

    Reviewed August 27, 2026 · 4 min read · 3 sources

    At a Glance

    The ceiling
    The device's cleared or approved labeling, including intended use and indications
    Off-label promotion
    Prohibited, even where off-label use by clinicians is itself lawful
    Read the reference
  • Medical equipment distribution

    Refurbished, Remanufactured, or Serviced: Words That Carry Weight

    Four words that sound like grades of the same thing. One of them changes who you are in the eyes of a regulator, and it is not the one most listings worry about.

    Reviewed August 27, 2026 · 4 min read · 3 sources

    At a Glance

    The test
    What was actually done to the device, not what the company calls itself
    Servicing
    Returns the device to the original manufacturer's specifications and original intended use
    Read the reference
  • eCommerce publishing

    Selling Medical Equipment Online: What Stands Behind a Listing

    The storefront is the easy part. What decides whether you can lawfully sell a given item to a given buyer sits in four places, and only one of them is in your ecommerce platform.

    Reviewed August 27, 2026 · 4 min read · 4 sources

    At a Glance

    State licensing
    Commonly required, often from a board of pharmacy or department of health
    Which state
    Usually the state you ship into, so multi state selling can mean multiple licences
    Read the reference

Elsewhere in Resources

Reference Explains the Rule. These Show the Work.

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