Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006361161

FEI Number

3006361161

Entity Name

NANTONG EGENS BIOTECHNOLOGY CO.,LTD.

City/State/Country

NANTONG Jiangsu, CN

Establishment Address

Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, NANTONG Jiangsu 226010, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NANTONG EGENS BIOTECHNOLOGY CO.,LTD. (Owner Number: 9103205)

Owner / Operator Contact Address

Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, NANTONG, CN-JS 226010, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA EGENS Follicle Stimulating Hormone (FSH) Test Midstream EGENS Follicle Stimulating Hormone (FSH) Test Cassette EGENS Follicle Stimulating Hormone (FSH) Test Strip EGENS Ovulation (LH) Test (strip, cassette, midstream)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-11-03
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-11-03
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2013-06-20
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2012-12-03

Official Correspondent

LL Su

US Agent Details

Joe Xia Business: LSI International Inc Email: jxia@lsi-consulting.org Phone: (301) 2500831

Related Public Records

Same Entity

NANTONG EGENS BIOTECHNOLOGY CO.,LTD.

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
K112236	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST	2011-09-19
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27

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

Similar Registrations

Registration Number	Establishment Name	Location
3008852306	Chemtron Biotech, Inc.	San Diego, CA, US
3008416529	MICRO DISTRIBUTING II, LTD.	Belton, TX, US
3005345870	W.H.P.M. Bioresearch & Technology Co., Ltd.	BEIJING, CN
3005641941	ABON BIOPHARM (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
2031229	PHAMATECH INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006361161. Last updated year: 2026. Please use registration number 3006361161 when referencing this establishment in official correspondence.