Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009896423

FEI Number

3009896423

Entity Name

MD DIAGNOSTICS LTD

City/State/Country

Chatham Kent, GB

Establishment Address

Slip 7 Annexe, The Historic Dockyard, Chatham Kent ME4 4TZ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MD Diagnostics Ltd (Owner Number: 10045293)

Owner / Operator Contact Address

Slip 7 Annexe,, The Historic Dockyard, Chatham, GB-KEN ME4 4TZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CARBON MONOXIDE MONITOR SafeBreath Filter Mouthpiece H2 Check

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	2018-03-05
JKT	Gas Chromatograph, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2018-03-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-05-01
NRH	System, Breath Measurement	Clinical Chemistry	Class 1	862.1820	2013-11-04

Official Correspondent

Daniel Quirke

US Agent Details

David Staszak Business: MICRO DIRECT INC Email: microdir@me.com Phone: (207) 7867808

Related Public Records

Same Entity

MD Diagnostics 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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Similar Registrations

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9612890	BEDFONT SCIENTIFIC LTD.	MAIDSTONE 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 3009896423. Last updated year: 2026. Please use registration number 3009896423 when referencing this establishment in official correspondence.