Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005395953

FEI Number

3005395953

Entity Name

SEJOY BIOMEDICAL CO., LTD.

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEJOY BIOMEDICAL CO., LTD. (Owner Number: 9078355)

Owner / Operator Contact Address

Area C,Building 2,No.365, Wuzhou Road,, Yuhang Economic Development Zone,, HANGZHOU, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LH One Step Ovulation Test Midstream,LH One Step Ovulation Test Strip,LH One Step Ovulation Test Cassette Vivoo At-Home Ovulation Test Vivoo At-Home Ovulation & Pregnancy Tests FSH One Step Menopause Test Midstream,FSH One Step Menopause Test Strip,FSH One Step Menopause Cassette Vivoo At-Home Fertility Test Vivoo At-Home Ovulation & Pregnancy Tests Sejoy hCG One Step Pregnancy Test Midstream Sejoy hCG One Step Pregnancy Test Cassette hCG One Step Pregnancy Test Midstream Sejoy hCG One Step Pregnancy Test Strip hCG One Step Pregnancy Test Strip hCG One Step Pregnancy Test Cassette

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	2021-03-26
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2021-03-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-02-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-10-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-10

Official Correspondent

YUNHUA REN

US Agent Details

EDMONDO N. ROARK Email: ce3@Sejoy.com Phone: (513) 2847182

Related Public Records

Same Entity

SEJOY BIOMEDICAL 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
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
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005395953. Last updated year: 2026. Please use registration number 3005395953 when referencing this establishment in official correspondence.