Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612890

FEI Number

3002806497

Entity Name

BEDFONT SCIENTIFIC LTD.

City/State/Country

MAIDSTONE Kent, GB

Establishment Address

STATION ROAD, HARRIETSHAM, MAIDSTONE Kent ME17 1JA, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BEDFONT SCIENTIFIC LTD. (Owner Number: 9033711)

Owner / Operator Contact Address

STATION ROAD, HARRIETSHAM, MAIDSTONE, KENT, GB-NOTA ME17 1JA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082315

PMA Number

N/A

All Registered Proprietary Names

EC50 Toxco+ GASTROGENIUS GastroCH4ECK Gastrolyzer Gastro+ Gastrolyzer HYDROGENIUS Gastro+ Gastrolyzer Hydrogenius Gastrogenius GastroCHECK Gastrolyzer FeNObreath NObreath® EC50 SMOKERLYZER CARBON MONOXIDE MO PICO SMOKERLYZER MODEL EC-50 C-50 MODEL EC-50 PICO SMOKERLYZER C-50 Pico+ADV Pico+Smokerlyzer EC50 SMOKERLYZER CARBON MONOXIDE MO Toxco iCOquit® Smokerlyzer® EC50 Micro+ Smokerlyser Micro+USA Micro+ Smokerlyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2010-01-15
NRH	System, Breath Measurement	Clinical Chemistry	Class 1	862.1820	2022-11-28
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2013-02-06
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2021-12-23
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2006-09-19
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2006-09-19
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2019-06-10
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2021-12-23
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-08-23
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2010-08-23
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2010-08-23

Official Correspondent

Louise Bateman

US Agent Details

Jason Aversano Business: CoVita Email: Jasona@covita.net Phone: (800) 7075751

Related Public Records

Same Entity

BEDFONT SCIENTIFIC LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3008614998	CAPNIA, INC.	Foster City, CA, US
3009896423	MD DIAGNOSTICS LTD	Chatham Kent, GB
9615102	Jaeger Medical GmbH	HOECHBERG Bavaria, DE
1223858	MICRO DIRECT, INC.	LEWISTON, ME, US
3014023337	Pivot Health Technologies Inc	San Carlos, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612890. Last updated year: 2026. Please use registration number 9612890 when referencing this establishment in official correspondence.