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Bedfont Scientific Ltd.: FDA-registered device maker in MAIDSTONE Kent, United Kingdom, 7 510(k) clearances

Name: Bedfont Scientific Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bedfont Scientific Ltd. is registered with the FDA (registration 9612890) in MAIDSTONE Kent, United Kingdom. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9612890
FEI number: 3002806497
Address: Station Road Harrietsham, MAIDSTONE Kent, United Kingdom, ME17 1JA
Owner or operator: BEDFONT SCIENTIFIC LTD. (9033711)
Roles: Manufacturer
First device listed: September 19, 2006
Registered through: 2026
Brand names listed: C-50, EC50 Micro+ Smokerlyser, EC50 SMOKERLYZER CARBON MONOXIDE MO, EC50 Toxco+, FeNObreath, GASTROGENIUS, Gastro+ Gastrolyzer, GastroCH4ECK Gastrolyzer and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	CCJ	2	Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer	accessdata.fda.gov
Drug Specific Control Materials	LAS	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
System, Breath Measurement	NRH	1	Manufacturer	accessdata.fda.gov
System, Test, Breath Nitric Oxide	MXA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 21, 2021	K211918	iCOquit® Smokerlyzer®	CCJ	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
December 17, 2021	K203695	NObreath®	MXA	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
April 4, 2019	K173238	ToxCO	CCJ	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
February 1, 2010	K082315	EC50 MICRO+ SMOKERLYZER	CCJ	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
February 21, 2008	K070259	EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR	CCJ	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
April 20, 2000	K000962	PICO SMOKERLYZER, MODEL EC-50	CCJ	Substantially Equivalent	Bedfont Scientific, Ltd.	accessdata.fda.gov
October 5, 1989	K892841	BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR	CCJ	Substantially Equivalent	Bedfont Technical Instruments , Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 21, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.