Unofficial mirror of a public FDA registerCopy dated 30 August 2026
Import Alert Watch
Listed supplier

Mareli Medical AB

This firm is named on 2 FDA import alerts in Sweden. Shipments from a listed firm may be detained at the port without physical examination. The oldest listing dates to 26 February 2019, the newest to 14 April 2026.

Every alert naming this firm

Source: FDA import alerts, mirrored 30 August 2026 · newest listing first

AlertSubjectCountryListed since
99-34Drugs or medical devices from firms without a valid drug or medical device registration and/or listing53----- · 73----- · 74----- · 76----- · 77----- · 78-----Sweden14 April 2026new
99-34Drugs or medical devices from firms without a valid drug or medical device registration and/or listing53----- · 73----- · 74----- · 76----- · 77----- · 78-----Sweden14 April 2026new
89-08Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)53L--03 · 53L--10 · 53L--99 · 53P--99 · 53Y--99 · 62C--04Sweden26 February 20197 yr

Product classes covered

A listing does not cover everything the factory makes — it covers the FDA product codes named on the alert. These are the codes attached to this firm, with the class FDA prints for each.

CodeProduct class
53-----Cosmetics
53L--03Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
53L--10Wrinkle Smoothing (Skin Care Preparations)
53L--99Other Skin Care Preparations, N.E.C.
53P--99Other Cosmetic Raw Materials, N.E.C.
53Y--99Other Cosmetic and Cosmetic Products, N.E.C.
62C--04Clonidine Transdermal Patches
73-----Anesthesiology
74-----Cardiovascular
76-----Dental
77-----Ear,Nose And Throat
78-----Gastroenterological & Urological

How the register writes this firm

FDA prints the name as the inspector wrote it, so one factory can appear under several spellings or addresses. All of them are shown — matching them to your invoice is on you.

Why this matters under FSVP

If you import this firm's food into the United States, the FSVP rule makes you re-evaluate the supplier when new information comes to light about its performance. An import alert listing is exactly that kind of information. What FSVP requires and where this fits.

Watch this firm

Being absent from a red list today says nothing about next month. The register is re-read every morning; give the name and an address, and the change comes to you instead of to the port.

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This page exists because the firm was on more than one alert when we first saw it, on 30 August 2026. It stays even after the listings come off, because FDA does not publish removals. What moved lately · check another supplier.