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Home›USA›Cambridge Sensors USA, LLC.

Cambridge Sensors USA, LLC.

USA · Plainfield
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
10listed device types
Class I 5Class II 5Class III 0
plus 15 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States15 registration records, 3 510(k), 0 PMA, 13 excluded
Manufacturer names merged into this page: CAMBRIDGE SENSORS LIMITED · Cambridge Sensors USA, LLC.
Same-named companies — This database also contains companies with near-identical names: CAMBRIDGE SENSORS LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Plainfield

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12007 · K070524
12009 · K083273
12012 · K102383

FDA listed device types

showing 8 of 10
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Needle, Hypodermic, Single Lumen 1Oximeter 1Glucose Dehydrogenase, Glucose 1System, Test, Blood Glucose, Over The Counter 1Fentanyl And Other Opioid Protection Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK102383MICRODOT & MICRODOT XTRA2012-01-27
USK083273MICRODOT XTRA2009-11-19
USK070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEM2007-06-22

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