Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014845771

FEI Number

3014845771

Entity Name

OWLSTONE MEDICAL LTD

City/State/Country

Cambridge Cambridgeshire, GB

Establishment Address

183 Cambridge Science Park, Milton Road, Cambridge Cambridgeshire CB4 0GJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Owlstone Medical Ltd (Owner Number: 10090765)

Owner / Operator Contact Address

183 Cambridge Science Park, Milton Road, Cambridge, GB-CAM CB4 0GJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OMED Health Breath Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRH	System, Breath Measurement	Clinical Chemistry	Class 1	862.1820	2024-05-10

Official Correspondent

Wendy Morgan

US Agent Details

Bryan Wittmann Email: bryan.wittmann@owlstone.co.uk Phone: (216) 5349557

Related Public Records

Same Entity

Owlstone Medical Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3014686722	FoodMarble Digestive Health Limited	Dublin 8, IE
3042956423	HUWANT CORP.	Daegu, KR
9612890	BEDFONT SCIENTIFIC LTD.	MAIDSTONE Kent, GB
2124914	QUINTRON INSTRUMENT CO. INC.	New Berlin, WI, US
3026284320	QI DIAGNOSTICS LIMITED	Mongkok Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014845771. Last updated year: 2026. Please use registration number 3014845771 when referencing this establishment in official correspondence.