Bedfont Scientific, Ltd. · 89-08 · UNITED KINGDOM

For Bedfont Scientific, Ltd., import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Flexpulse | GastroCHECK Gastrolyzer | GastroCHECK Gastrolyzer | GastroCHECK Gastrolyzer | Flexpulse | Flexpulse; product code is 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use | 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use | 75 N - - RH System, Breath Measurement | 82 M - - VM Autoantibodies, Endomysial (Tissue Transglutaminase) | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 06/04/2019; address is Station Road , Maidstone, Kent UNITED KINGDOM, verified against its source on 2026-09-30.

What the source says

Bedfont Scientific, Ltd. Date Published : 06/04/2019 Station Road , Maidstone, Kent UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.