FDA Registration
Active
🇬🇧 United Kingdom
BEDFONT SCIENTIFIC LTD.
Reg #: 9612890
·
FEI: 3002806497
·
Expires 2026
Products
6
Proprietary Names
21
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BEDFONT SCIENTIFIC LTD.
- Registration Number
- 9612890
- FEI Number
- 3002806497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- STATION ROAD, HARRIETSHAM
- City
- MAIDSTONE Kent
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K070259
Owner / Operator
- Firm Name
- BEDFONT SCIENTIFIC LTD.
- Operator Number
- 9033711
- Address
- STATION ROAD, HARRIETSHAM
- City
- MAIDSTONE, KENT
- State
- GB-NOTA
- Postal Code
- ME17 1JA
- Country
- GB
- Correspondent
- Louise - Bateman
US Agent
- Business Name
- CoVita
- Contact Name
- Jason Aversano
- Address
- 3200 Research Forest Dr Ste A1
- City
- The Woodlands
- State
- TX
- ZIP
- 77381
- Country
- US
- [email protected]
- Phone
- 800 7075751
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | Class 2 | Anesthesiology | No | 2010-01-15 |
| System, Breath Measurement | NRH | Class 1 | Clinical Chemistry | No | 2022-11-28 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2013-02-06 |
| System, Test, Breath Nitric Oxide | MXA | Class 2 | Clinical Toxicology | No | 2021-12-23 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2010-08-23 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2010-08-23 |
Proprietary Names
EC50 Toxco+
GASTROGENIUS
GastroCH4ECK Gastrolyzer
Gastro+ Gastrolyzer
HYDROGENIUS
Hydrogenius
Gastrogenius
GastroCHECK Gastrolyzer
FeNObreath
NObreath®
EC50 SMOKERLYZER CARBON MONOXIDE MO
PICO SMOKERLYZER
MODEL EC-50
C-50
Pico+ADV
Pico+Smokerlyzer
Toxco
iCOquit® Smokerlyzer®
EC50 Micro+ Smokerlyser
Micro+USA
Micro+ Smokerlyzer
Establishment Types
Manufacture Medical Device