Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003966680

FEI Number

3003966680

Entity Name

Biomedical Data Solutions Limited

City/State/Country

BURTON ON TRENT Staffordshire, GB

Establishment Address

Millennium Court, First Avenue, Centrum 100, BURTON ON TRENT Staffordshire DE14 2WH, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biomedical Data Solutions Limited (Owner Number: 9054990)

Owner / Operator Contact Address

Millennium Court, First Avenue, Centrum 100, BURTON ON TRENT, GB-STS DE14 2WH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK160124

PMA Number

N/A

All Registered Proprietary Names

Procleix NAT Manager v1.2 Software Procleix NAT Manager v1.3 Software Procleix NAT Manager V1.4 Software Ortho Connect 3 Ortho Connect 3.2 Ortho Connect 3.2.1 Ortho Connect 3.2.3 Ortho Connect 31 Ortho Connect 3.2.2 Ortho Connect 3.2.4 Aurora TOUCH Sanguin Aurora v2 Aurora Gold V3 Aurora Gold V3.2 Aurora Gold V2 Aurora Enterprise Procleix NAT Manager Software (Version 1.1) Sanguin Liberty SR Import v3.1 ORTHO CONNECT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQQ	Data Acquisition Software	Clinical Chemistry	Class 2	862.2570	2018-09-19
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2020-07-09
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2012-12-17
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2018-11-21
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2016-05-06
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2012-12-17
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2018-09-19

Official Correspondent

Rebecca Stead

US Agent Details

Kevin Ewald Email: kewald@biomedical-ds.com Phone: (805) 5513044

Related Public Records

Same Entity

Biomedical Data Solutions Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003966680. Last updated year: 2026. Please use registration number 3003966680 when referencing this establishment in official correspondence.