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Safecare Biotech (Hangzhou) Co., Ltd.

China·CN-MF-000019109

Last updated May 23, 2026

What Safecare Biotech (Hangzhou) Co., Ltd. makes

Safecare Biotech produces rapid in vitro diagnostic (IVD) tests for clinical, self-testing, and screening use, including kits for detecting drugs of abuse, cannabinoids, nicotine metabolites, vaginal pH levels, and reproductive hormones. Their portfolio also covers multi-analyte urine tests, antigen-based tests for respiratory infections, and specific metabolite or drug assays like cotinine, 6-MAM, and MDPV. Examples include rapid colorimetric or immunochromatographic tests for substances such as acetaminophen, cardiac troponin I, and herpes simplex virus antibodies. The company also offers rapid tests for hormones like luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

The company’s diagnostic devices are classified under Class I and Class II regulations, with a focus on in vitro diagnostics (IVDs) for both general clinical use and self-testing applications. Their products are listed in the EU’s EUDAMED registry and the U.S. FDA’s Unique Device Identifier (UDI) database. Safecare Biotech is headquartered in Hangzhou, China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: Building 2/203, No.18 Haishu Rd.Cangqian Sub-district，Yuhang District, HANGZHOU, China
Website: safecare.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Selina Zhang
EUDAMED SRN: CN-MF-000019109
FDA FEI Number: —
DUNS Number: 544349634

Catalogue (342)

Page 7 of 7

Device	Model / Reference	Registries	Class	Status
Exploro Highly Sensitive 5-Panel Urine Drug Test	5 tests	FDA UDI	Class II	Active
EXPLORO Highly Sensitive THC Test	50 tests	FDA UDI	Class II	Active
T Testahead HCG Urine Test Strip	50 Tests	FDA UDI	Class II	Active
Exploro Highly Sensitive 5-Panel Urine Drug Test	7 tests	FDA UDI	Class II	Active
EXPLORO Highly Sensitive NICOTINE URINE TEST	20 tests	FDA UDI	Class I	Active
Testahead Vaginal PH Rapid Test Cassette	PH-6012	FDA UDI	Class I	Active
FIRSTVIEW Luteinizing Hormone Rapid Test Strip	15 tests	FDA UDI	Class I	Active
FIRSTVIEW Urine Test Marijuana DipCard	THC-1014	FDA UDI	Class II	Active
FIRSTVIEW Cocaine(COC) Urine Test Dipcard	COC-1014	FDA UDI	Class II	Active
T Testahead URINARY TRACT INFECTION TEST	6 tests	FDA UDI	Class I	Active
EXPLORO Highly Sensitive NICOTINE URINE TEST	15 tests	FDA UDI	Class I	Active
T Testahead Marijuana(THC) Urine Test Dipcard	5 tests	FDA UDI	Class II	Active
T Testahead Cotinine(COT) Urine Test Dipcard	20 tests	FDA UDI	Class I	Active
Exploro Vaginal Health pH Test Device	15 Tests	FDA UDI	Class I	Active
EXPLORO Highly Sensitive THC Test	3 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	5 tests	FDA UDI	Class II	Active
Exploro 7-Panel Urine Drug Test	7 tests	FDA UDI	Class II	Active
Exploro Vaginal Health pH Test Device	3 Tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (14-Panel)	3 tests	FDA UDI	Class II	Active
Vaginal PH Rapid Test Cassette	10 Tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (5-Panel)	7 tests	FDA UDI	Class II	Active
T Testahead URINARY TRACT INFECTION TEST	12 tests	FDA UDI	Class I	Active
FIRSTVIEW Fentanyl Urine Test Cassette	5 tests	FDA UDI	Class II	Active
EXPLORO Highly Sensitive NICOTINE URINE TEST	5 tests	FDA UDI	Class I	Active
Exploro 7-Panel Urine Drug Test	15 tests	FDA UDI	Class II	Active
Highly Sensitive Nicotine Urine Test	COT-1011	FDA UDI	Class I	Active
Welcheck Vaginal PH Rapid Test Cassette	15 Tests	FDA UDI	Class I	Active
Luteinizing Hormone Rapid Test Strip	LH-1011	FDA UDI	Class I	Active
T Testahead HCG Urine Test Strip	25 Tests	FDA UDI	Class II	Active
Exploro Vaginal Health pH Test Device	7 Tests	FDA UDI	Class I	Active
hCG Pregnancy Test For Self testing	HCG-1011/HCG-1012/HCG-1013	EUDAMED	IVD devices for self-testing	Active
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	K182654	FDA 510(k)	Class II	Active
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette	K240654	FDA 510(k)	Class II	Active
Safecare Urinary Tract Infection Test	K242767	FDA 510(k)	Class I	Active
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	K202453	FDA 510(k)	Class II	Active
SAFECARE® THC Urine Strip Test	K191924	FDA 510(k)	Class II	Active
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana	K153646	FDA 510(k)	Class II	Active
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	K201120	FDA 510(k)	Class II	Active
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	K181968	FDA 510(k)	Class II	Active
Safecare THC Rapid Test Panel (Saliva)	THC-7014	EUDAMED	IVD General	Active
COVID-19 Antigen Rapid Test Kit (Swab)	COV Ag-6012H	EUDAMED	IVD devices for self-testing	Active
COVID-19 & Influenza A+B Antigen Combo Rapid Test	FCO-6032H	EUDAMED	IVD devices for self-testing	Active

Safecare Biotech (Hangzhou) Co., Ltd.

What Safecare Biotech (Hangzhou) Co., Ltd. makes

Information

Catalogue (342)

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