Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005216656

FEI Number

3005216656

Entity Name

Equinox Biotech Co., Ltd.

City/State/Country

Shantou Guangdong, CN

Establishment Address

Rongsheng Technological Zone, UNIVERSITY ROAD,, Shantou Guangdong 515063, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Equinox Biotech Co., Ltd. (Owner Number: 9074282)

Owner / Operator Contact Address

No. 12, Gaoxin 2nd Road, Huadu District, Guangzhou, CN-GD 510800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172627

PMA Number

N/A

All Registered Proprietary Names

DAVID OVULATION TEST KIT DAVID Ovulation & Pregnancy DAVID OVULATION AND PREGNANCY TEST KIT DAVID Ovulation & Pregnancy Test 6 Days Ahead Pregnancy Test DAVID One Step Prescription Pregnancy Test Cassette Early Blush Pregnancy Test DAVID One Step Home Use Pregnancy Test Midstream DAVID One Step Home Use Pregnancy Test Cassette PREGABLE Pregnancy Test DAVID One Step Prescription Pregnancy Test Strip DAVID One Step Home Use Pregnancy Test Strip Smilereader Pregnancy Test DAVID One Step Prescription Pregnancy Test Midstream DAVID Pregnancy Test Strip DAVID Ovulation & Pregnancy Test Kit DAVID Pregnancy Test Midstream DAVID Pregnancy Test DAVID Ovulation & Pregnancy Test One Step Pregnancy Test Smilereader pregnancy test DAVID ONE STEP OVULATION TEST MIDSTREAM DAVID ONE STEP OVULATION TEST CASSETTE DAVID ONE STEP OVULATION TEST STRIP DAVID One Step Semi-quantitative Ovulation Test David Home Pregnancy Test Cassette David Professional Pregnancy Test Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2016-08-12
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2019-04-23
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2019-04-23
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2006-09-25
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2016-04-21
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2019-08-15
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2019-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

Boyuan Chen Email: runhe0754@126.com Phone: (817) 8211070

Related Public Records

Same Entity

Equinox Biotech 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-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005216656. Last updated year: 2026. Please use registration number 3005216656 when referencing this establishment in official correspondence.