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Safecare Biotech(hangzhou)co.,ltd: FDA-registered device maker in Huzhou Zhejiang, China, 9 510(k) clearances

Name: Safecare Biotech(hangzhou)co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Safecare Biotech(hangzhou)co.,ltd is registered with the FDA (registration 3013077867) in Huzhou Zhejiang, China. It lists 22 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013077867
Address: No.689, Changxing Avenue, Taihu Street, Changxing County, Huzhou Zhejiang, China, 313100
Owner or operator: Safecare Biotech(Hangzhou)Co.,Ltd (10052102)
Roles: Manufacturer
First device listed: June 14, 2016
Registered through: 2026
Brand names listed: 2San Vaginal pH Rapid Test Cassette, Cubtale Ovulation (LH) Test Strip, Cwhole Vaginal PH Rapid Test Cassette, EXPLORO Highly Sensitive NICOTINE URINE TEST, Exploro Vaginal Health pH Test Device, FIRSTVIEW COT Saliva Cassette Test, FIRSTVIEW COT Saliva Cup Test, FIRSTVIEW COT Saliva Dip Card Test and more

Devices it lists

Device	Product code	Class	Role	Source
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Paper, Obstetric Ph	LNW	1	Manufacturer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	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	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, Morphine, Over The Counter	NGI	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
Test, Urine Leukocyte	LJX	1	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
January 10, 2025	K242767	Safecare Urinary Tract Infection Test	JMT	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
April 10, 2024	K240654	SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette	NGL	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
March 24, 2021	K202453	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	NFT	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
August 13, 2020	K200133	hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream	LCX	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
May 27, 2020	K201120	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	NFT	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
August 16, 2019	K191924	SAFECARE® THC Urine Strip Test	NFW	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
November 19, 2018	K182654	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	NGG	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
August 20, 2018	K181968	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	NFT	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov
March 18, 2016	K153646	SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana	DIO	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 10, 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.