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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 6 of 7

Device	Model / Reference	Registries	Class	Status
Malaria P.v. Rapid Test (Whole Blood)	MAL-4011b/MAL-4012b	EUDAMED	IVD General	Active
Synthetic Cannabis(K2) Rapid Test (Saliva)	K2-7012/K2-7014/K2-7015	EUDAMED	IVD General	Active
FIRSTVIEW Luteinizing Hormone Rapid Test Strip	LH-1011	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (5-Panel)	2 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive 5-Panel Urine Drug Test	3 tests	FDA UDI	Class II	Active
FIRSTVIEW hCG Urine Test Strip	HCG-1011	FDA UDI	Class II	Active
Welcheck Vaginal PH Rapid Test Cassette	7 Tests	FDA UDI	Class I	Active
T Testahead Vaginal PH Rapid Test Cassette	10 Tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	10 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive 5-Panel Urine Drug Test	2 tests	FDA UDI	Class II	Active
T Testahead Multi-Drug Urine Test Dip Card	10 tests	FDA UDI	Class II	Active
Welcheck Marijuana(THC) Urine Test Dipcard	15 tests	FDA UDI	Class II	Active
Welcheck Marijuana(THC) Urine Test Dipcard	7 tests	FDA UDI	Class II	Active
T Testahead Marijuana(THC) Urine Test Dipcard	12 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (5-Panel)	5 tests	FDA UDI	Class II	Active
Exploro Vaginal Health pH Test Device	2 Tests	FDA UDI	Class I	Active
T Testahead Cotinine(COT) Urine Test Dipcard	12 tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (5-Panel)	3 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (14-Panel)	4 tests	FDA UDI	Class II	Active
Urinary Tract Infection Test	5 tests	FDA UDI	Class I	Active
Welcheck URINARY TRACT INFECTION TEST	7 tests	FDA UDI	Class I	Active
Exploro 7-Panel Urine Drug Test	10 tests	FDA UDI	Class II	Active
THC Urine Strip Test	THC-1011	FDA UDI	Class II	Active
Welcheck Vaginal PH Rapid Test Cassette	3 Tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (5-Panel)	10 tests	FDA UDI	Class II	Active
T Testahead Multi-Drug Urine Test Dip Card	5 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (14-Panel)	1 test	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	3 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	1 test	FDA UDI	Class II	Active
7-Panel Urine Drug Test	MDP-1074	FDA UDI	Class II	Active
EXPLORO Highly Sensitive NICOTINE URINE TEST	25 tests	FDA UDI	Class I	Active
EXPLORO Highly Sensitive THC Test	20 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	4 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive 5-Panel Urine Drug Test	10 tests	FDA UDI	Class II	Active
FIRSTVIEW Luteinizing Hormone Rapid Test Strip	LH-1011	FDA UDI	Class I	Active
EXPLORO Highly Sensitive THC Test	5 tests	FDA UDI	Class II	Active
Exploro Highly Sensitive Urine Drug Test (12-Panel)	2 tests	FDA UDI	Class II	Active
FIRSTVIEW Luteinizing Hormone Rapid Test Strip	35 tests	FDA UDI	Class I	Active
Vaginal PH Rapid Test Cassette	5 Tests	FDA UDI	Class I	Active
EXPLORO Highly Sensitive THC Test	7 tests	FDA UDI	Class II	Active
Welcheck URINARY TRACT INFECTION TEST	3 tests	FDA UDI	Class I	Active
Exploro Highly Sensitive Urine Drug Test (14-Panel)	10 tests	FDA UDI	Class II	Active
T Testahead Multi-Drug Urine Test Dip Card	5 tests	FDA UDI	Class II	Active
Exploro Vaginal Health pH Test Device	5 Tests	FDA UDI	Class I	Active
Welcheck HCG Urine Test Midstream	5 Tests	FDA UDI	Class II	Active
EXPLORO Highly Sensitive THC Test	THC-1011	FDA UDI	Class II	Active
Exploro 7-Panel Urine Drug Test	2 tests	FDA UDI	Class II	Active
Exploro Vaginal Health pH Test Device	10 Tests	FDA UDI	Class I	Active
FIRSTVIEW COT Urine Dip card Test	COT-1014	FDA UDI	Class I	Active
Exploro 7-Panel Urine Drug Test	3 tests	FDA UDI	Class II	Active

Safecare Biotech (Hangzhou) Co., Ltd.

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

Information

Catalogue (342)

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