i-SENS, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146970303014697030i-SENS, Inc.1N2020-04-254th floor, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu Incheon Gwangyeogsiv KR 21655

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
00885325000856KetoSens - KetoSens B-Ketone Monitoring System with Lancets1-800-429-5001cs1@i-sens.com
00885325001495KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)1-800-429-5001cs1@i-sens.com
10885325000853KetoSens - KetoSens B-Ketone Monitoring System with Lancets1-800-429-5001cs1@i-sens.com
10885325001492KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)1-800-429-5001cs1@i-sens.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2280051746346829K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS2019-02-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GJS12019-02-21

PMN#

GUDID#

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