Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016585366

FEI Number

3016585366

Entity Name

DIRECTED SYSTEMS LTD

City/State/Country

Cambridge Cambridgeshire, GB

Establishment Address

47-51 Norfolk Street, Cambridge Cambridgeshire CB1 2LD, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Directed Systems Ltd (Owner Number: 10062519)

Owner / Operator Contact Address

47-51 Norfolk Street, Cambridge, GB-CAM CB1 2LD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190955

PMA Number

N/A

All Registered Proprietary Names

Hypotension Decision Assist (HDA)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2020-02-27

Official Correspondent

Mark Leaning

US Agent Details

Paul Coss Email: coss.paul@gmail.com Phone: (978) 8210727

Related Public Records

Same Entity

Directed Systems Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3015418961	RETIA MEDICAL SYSTEMS INC	White Plains, NY, US
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016585366. Last updated year: 2026. Please use registration number 3016585366 when referencing this establishment in official correspondence.