Data / Medical devices / China / Anhui Deepblue Medical Technology Co., Ltd.

Anhui Deepblue Medical Technology Co., Ltd.: FDA-registered device maker in Hefei Anhui, China, 3 510(k) clearances

Name: Anhui Deepblue Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Anhui Deepblue Medical Technology Co., Ltd. is registered with the FDA (registration 3016447251) in Hefei Anhui, China. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Anhui Deepblue Medical Technology Co., Ltd.

FDA registration number: 3016447251
Address: No. 777 Jimingshan Road High-Tech Development Zone, Hefei Anhui, China, 230088
Owner or operator: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. (10062344)
Roles: Contract manufacturer, Manufacturer
First device listed: June 11, 2023
Registered through: 2026
Brand names listed: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup, Follicle-Stimulating Hormone (FSH) Menopause test, HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold), Luteinizing Hormone (LH) Ovulation test, Ovulation Test + Pregnancy Test Combo, Sterile and Non-Sterile Ultrasonic Coupling Agent

Devices it lists

Device	Product code	Class	Role	Source
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Media, Coupling, Ultrasound	MUI	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 15, 2025	K250803	Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup	NGL	Substantially Equivalent	Anhui Deepblue Medical Technological Co., Ltd.	accessdata.fda.gov
October 11, 2024	K240242	HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)	LCX	Substantially Equivalent	Anhui Deepblue Medical Technology Co., Ltd.	accessdata.fda.gov
September 19, 2024	K242167	Sterile and Non-Sterile Ultrasonic Coupling Agent	MUI	Substantially Equivalent	Anhui Deepblue Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.