Bedfont Scientific, Ltd. · 89-08 · UNITED KINGDOM
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
- 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
- Address
- Station Road , Maidstone, Kent UNITED KINGDOM verified
- Date published
- 06/04/2019 verified
- 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 each item verified
- Product
- GastroCHECK Gastrolyzer | Flexpulse | GastroCHECK Gastrolyzer | GastroCHECK Gastrolyzer | Flexpulse | Flexpulse each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html