Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010879605

FEI Number

3010879605

Entity Name

SUGENTECH, INC.

City/State/Country

Cheongju-si Chungbuk, KR

Establishment Address

721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk 28161, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sugentech, Inc. (Owner Number: 10046776)

Owner / Operator Contact Address

721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, Cheongju-si, KR-43 28161, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surearly Digital Ovulation Test Surearly Ovulation Test Strip Surearly SMART Ovulation Test Surearly SMART Surearly SMART Ovulation Test Starter Kit pettyPip Surearly Digital Pregnancy Test Surearly Pregnancy Test Strip Surearly SMART Menopause Test Surearly SMART

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2014-05-11
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2020-04-07
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-04-08
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Sugentech, Inc.

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
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

Similar Registrations

Registration Number	Establishment Name	Location
3013124221	MERIL DIAGNOSTICS PVT. LTD.	Vapi Gujarat, IN
3015729142	Winx Health Inc	Reading, PA, US
3027500452	TRUE DIAGNOSTICS, INC.	Carlsbad, CA, US
3013885851	CENTUM ELECTRONICS LIMITED	Bangalore Karnataka, IN
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010879605. Last updated year: 2026. Please use registration number 3010879605 when referencing this establishment in official correspondence.