Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016447251

FEI Number

3016447251

Entity Name

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Hefei Anhui, CN

Establishment Address

No. 777 Jimingshan Road, High-Tech Development Zone, Hefei Anhui 230088, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. (Owner Number: 10062344)

Owner / Operator Contact Address

No. 777 Jimingshan Road, High-Tech Development Zone, Hefei, CN-AH 230088, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile and Non-Sterile Ultrasonic Coupling Agent HCG Home Use Pregnancy Test Strip (Colloidal Gold) HCG Home Use Pregnancy Test Midstream (Colloidal Gold) Ovulation Test + Pregnancy Test Combo HCG Home Use Pregnancy Test Cassette (Colloidal Gold) Follicle-Stimulating Hormone (FSH) Menopause test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2024-10-28
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-10-28
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2024-10-28
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-12-14

Official Correspondent

Fengling Chen

US Agent Details

Gloria Wang Business: Medlinkt Business Technology Inc Email: Medlinkt.global@gmail.com Phone: (307) 7769129

Related Public Records

Same Entity

ANHUI DEEPBLUE MEDICAL TECHNOLOGY 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

Similar Registrations

Registration Number	Establishment Name	Location
3031569584	EDGECARE INC.	Yeongdeungpo-gu Seoul, KR
3008502431	HR PHARMACEUTICALS, INC d/b/a HR HealthCare	York, PA, US
3008751375	PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H.	Absam Tirol, AT
2212018	PARKER LABORATORIES, INC.	FAIRFIELD, NJ, US
3007143236	MING FAI ENTERPRISE INTERNATIONAL CO., LTD	Kowloon, Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016447251. Last updated year: 2026. Please use registration number 3016447251 when referencing this establishment in official correspondence.