# Bedfont Scientific, Ltd. · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Bedfont Scientific, Ltd. · 89-08 · UNITED KINGDOM, import alert is 89-08; 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)"; country is UNITED KINGDOM; product is GastroCHECK Gastrolyzer | Flexpulse | 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 2026-09-16.

- **Firm:** Bedfont Scientific, Ltd. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Station Road , Maidstone, Kent UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 06/04/2019 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** GastroCHECK Gastrolyzer | Flexpulse | GastroCHECK Gastrolyzer | GastroCHECK Gastrolyzer | Flexpulse | Flexpulse _(verified: each item appears in the quote below)_

## What the source says

> Bedfont Scientific, Ltd. Date Published : 06/04/2019 Station Road , Maidstone, Kent UNITED KINGDOM 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 12/03/2019 Desc: GastroCHECK Gastrolyzer 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 06/04/2019 Desc: Flexpulse 75 N - - RH System, Breath Measurement Date Published: 12/03/2019 Desc: GastroCHECK Gastrolyzer 82 M - - VM Autoantibodies, Endomysial (Tissue Transglutaminase) Date Published: 12/03/2019 Desc: GastroCHECK Gastrolyzer 89 I - - SA Massager, Therapeutic, Electric Date Published: 06/04/2019 Desc: Flexpulse 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 06/04/2019 Desc: Flexpulse

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).