Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014937935

FEI Number

3014937935

Entity Name

SENTECH GMI Corp

City/State/Country

Seoul, KR

Establishment Address

#1713~1714, 416, Hwagok-ro,, Gangseo-gu, Seoul 07548, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sentech Korea Corp (Owner Number: 9066277)

Owner / Operator Contact Address

21-6, Jimok-ro, 75beon-gil, Paju-Si, KR-41 10880, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KETOSCAN Mini KETOSCAN KETOSCAN Lite MultiGenix KETOSCAN SMART

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRH	System, Breath Measurement	Clinical Chemistry	Class 1	862.1820	2018-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

Sentech Korea Corp

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003383868	SENTECH KOREA CORP.	PAJU-SI Gyeonggi, KR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014937935. Last updated year: 2026. Please use registration number 3014937935 when referencing this establishment in official correspondence.