Bedfont Scientific Ltd
GB-MF-000010889 · United Kingdom · Maidstone
Bedfont Scientific Ltd is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: D-Piece, Gastrolyzer, OneBreath, Smokerlyzer.
Among these devices, 9 are declared active, 9 with a measuring function.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- D-Piece
- Facemask Sampling System
- Gastro+
- GastroGenius
- Gastrocheck Mouthpiece
- Gastrolyzer
- HydroGenius
- Micro+
- NObreath Mouthpiece
- OneBreath
- PICOBABY
- PiCO
Showing 12 of 17 declared devices.
Catalogue references include GASTROCHECK UK, GASTROCHECK-MP-50, ICOQUIT, ISSA-V-2, LMTCH4, LMTH2.
European nomenclature codes declared: R040101, Z12159006, Z1203020402, Z1203020485, R9001, W05020105.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BEDFONT SCIENTIFIC LTD. (GB) · FDA 9612890 |
| Devices in EUDAMED | 17 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 58.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BEDFONT SCIENTIFIC LIMITED |
North American profile: Both markets. Bedfont Scientific Ltd is registered in both the United States and Canada.