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EPOCAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049597933004959793EPOCAL, INC.1N2026-01-012060 Walkley Road Ottawa Ontario CA K1G-3P5
30128172283012817228Epocal Inc1N2026-01-01855 Brookfield Road Ottawa Ontario CA K1V 2S5

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00630414606095epoc NXS Host - The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions.+1(877)229-3711XX@XX.XX
00630414606095epoc NXS Host - The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions.+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2128871749010452K200107epoc Blood Analysis SystemCHL2020-06-05
3380571749010452K200107epoc Blood Analysis SystemCHL2020-06-05
2128871732996115K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS2018-01-17
2128871240807102K113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTCGL2012-10-05
2128871822004218K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEKHP2010-06-09
2128871303488967K092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZERCEM2010-03-30
2128871143978332K090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDCGA2009-06-24
2128871085836598K061597EPOC BLOOD ANALYSIS SYSTEMJGS2006-09-27
3380571085836598K061597EPOC BLOOD ANALYSIS SYSTEMJGS2006-09-27
2128871376055993

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHL22020-06-05
JGS22006-09-27
CDS12018-01-17
CGL12012-10-05
KHP12010-06-09
CEM12010-03-30
CGA12009-06-24

PMN#

GUDID#

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