CAMBRIDGE SENSORS LIMITED

FDA Device Registration & Listing · HUNTINGDON, Cambridgeshire, GB · Registration 3004176168

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004176168
FEI Number
3004176168
Entity Name
CAMBRIDGE SENSORS LIMITED
City/State/Country
HUNTINGDON, Cambridgeshire, GB
Establishment Address
UNITS 9&10 CARDINAL PARK, GODMANCHESTER, HUNTINGDON, Cambridgeshire PE29 2XG, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CAMBRIDGE SENSORS LIMITED (Owner Number: 9057881)
Owner / Operator Contact Address
UNITS 9&10 CARDINAL PARK, GODMANCHESTER, HUNTINGDON, GB-CAM PE29 2XG, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Microdot Xtra Test Strips Microdot Test Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-02-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-02-18
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2010-02-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2008-02-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-02-14
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2008-02-14

Official Correspondent

No official correspondent registered.

US Agent Details

FRED ENGIMANN Business: CAMBRIDGE SENSORS USA, LLC Email: fengimann@microdotcs.com Phone: (630) 4284240

Related Public Records

Same Entity

CAMBRIDGE SENSORS LIMITED
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
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number Establishment Name Location
3005706626 Bioptik Technology, Inc. Jhunan Township Miaoli, TW
3004539335 CONDUCTIVE TECHNOLOGIES, INC. York, PA, US
3014302067 MICROTECH MEDICAL (HANGZHOU) CO., LTD. Hangzhou Zhejiang, CN
3014353121 VIDAN DIAGNOSTICS, LLC San Antonio, TX, US
3008514395 Telcare, LLC Linwood, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004176168. Last updated year: 2026. Please use registration number 3004176168 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.