Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Selina Zhang
EUDAMED SRN
CN-MF-000019109
FDA FEI Number
—
DUNS Number
544349634

Catalogue (342)

Page 5 of 7
DeviceModel / ReferenceRegistriesClassStatus
Chagas Rapid Test (Whole Blood/Serum/Plasma) CHA-4011/CHA-4012
EUDAMED
IVD GeneralActive
Cholera O1 Antigen Rapid Test CHO-5012
EUDAMED
IVD GeneralActive
Myoglobin Rapid Test (Serum/Plasma) MYO-3012
EUDAMED
IVD GeneralActive
Barbiturates(BAR) Rapid Test Kit(Urine) BAR-1011/BAR-1012/BAR-1014
EUDAMED
IVD GeneralActive
Ecstasy(MDMA) Rapid Test (Saliva) MDMA-7011/MDMA-7012/MDMA-7014/MDMA-7015
EUDAMED
IVD GeneralActive
Monkeypox Virus Antigen Rapid Test MON Ag-4012/MON Ag-3012/MON Ag-6012
EUDAMED
IVD GeneralActive
Cocaine(COC) Rapid Test(Saliva) COC-7011/COC-7012/COC-7014/COC-7015
EUDAMED
IVD GeneralActive
Rotavirus-Adenovirus-Astrovirus Combo Rapid Test (Feces) MID-5032b
EUDAMED
IVD GeneralActive
Methylenedioxypyrovalerone(MDPV) Rapid Test MDPV-1011/MDPV-1012/MDPV-1014/MDPV-7012/MDPV-7014
EUDAMED
IVD GeneralActive
Cotinine(COT) Rapid Test(Saliva) COT-7011/COT-7012/COT-7014/COT-7015
EUDAMED
IVD GeneralActive
Cholera O1 Antigen Rapid Test(Feces) CHO-5012
EUDAMED
IVD GeneralActive
Lysergic acid diethylamide(LSD) Rapid Test Kit(Urine) LSD-1011/LSD-1012/LSD-1014
EUDAMED
IVD GeneralActive
Calprotectin Antigen Rapid Test (Feces) CAL-5012
EUDAMED
IVD GeneralActive
Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) FCRA-6052
EUDAMED
IVD GeneralActive
Strep B Rapid Test Kit (swab) STB-6011/STB-6012
EUDAMED
IVD GeneralActive
Phosphorylated Tau-217 Protein Rapid Test Tau217-4011/Tau217-3011/Tau217-4012/Tau217-3012
EUDAMED
IVD GeneralActive
Malaria P.f./Pan Rapid Test (Whole Blood) MAL-4022b
EUDAMED
IVD GeneralActive
Cannabidiol(CBD)Rapid Test(Urine) CBD-1011/CBD-1012/CBD-1014
EUDAMED
IVD GeneralActive
Multi drug Rapid Saliva Test MDD-7**2/MDP-7**3/MDC-7**5
EUDAMED
IVD GeneralActive
Amphetamine(AMP) Rapid Test Kit(Urine) AMP-1011/AMP-1012/AMP-1014
EUDAMED
IVD GeneralActive
Acetaminophen(ACE) Rapid Test(Saliva) ACE-7011/ACE-7012/ACE-7014/ACE-7015
EUDAMED
IVD GeneralActive
Calprotein Rapid Test (Feces) CAL-5012
EUDAMED
IVD GeneralActive
Leishmaniasis Rapid Test (Whole Blood/serum/plasma) LEI-4011/LEI-4012
EUDAMED
IVD GeneralActive
Hantavirus IgG/IgM Rapid Test(WB/S/P) HV-4022
EUDAMED
IVD GeneralActive
Methylphenidate(MPD) Rapid Test(Saliva) MPD-7011/MPD-7012/MPD-7014/MPD-7015
EUDAMED
IVD GeneralActive
Brucella IgG/IgM Rapid Test (Serum/Plasma) Bru-3022
EUDAMED
IVD GeneralActive
Dengue NS1 Rapid Test Kit(Whole Blood/serum/plasma) DEN-4012
EUDAMED
IVD GeneralActive
Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal COV Ag-6012H
EUDAMED
IVD devices for self-testingActive
Multi drug Rapid Saliva Test MDD-1xx2/MDP-1xx4/MDC-1xx5
EUDAMED
IVD GeneralActive
Cotinine(COT) Rapid Test Kit (Urine) COT-1011/COT-1012/COT-1014
EUDAMED
IVD GeneralActive
COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test FCRAhH-6082
EUDAMED
IVD GeneralActive
Creatine Kinase-MB(CKMB) Rapid Test (Serum/Plasma) CKMB-3012
EUDAMED
IVD GeneralActive
Zika IgM/IgG Rapid Test(Serum/Plasma) ZIKA-3022
EUDAMED
IVD GeneralActive
Rotavirus Rapid Test (Feces) ROT-5011/ROT-5012
EUDAMED
IVD GeneralActive
Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma) HAV-4012
EUDAMED
IVD GeneralActive
Legionella & S.pneumoniae Antigen Combo Rapid Test(Urine) MID-1022
EUDAMED
IVD GeneralActive
Strep A Rapid Test (Swab) STA-6011/STA-6012
EUDAMED
IVD GeneralActive
Micro-Albumin Rapid Test Kit(Urine) ALB-1011/ALB-1012/ALB-1014
EUDAMED
IVD GeneralActive
H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-5012
EUDAMED
IVD GeneralActive
Carisoprodol(SOMA) Rapid Test(Urine) SOMA-1011/SOMA-1012/SOMA-1014
EUDAMED
IVD GeneralActive
Methcathinone(MCAT) Rapid Test(Saliva) MCAT-7011/MCAT-7012/MCAT-7014/MCAT-7015
EUDAMED
IVD GeneralActive
Rotavirus-Adenovirus-Norovirus-Astrovirus Combo Rapid Test(Feces) MID-5042
EUDAMED
IVD GeneralActive
Malaria Pan Rapid Test (Whole Blood) MAL-4011c/MAL-4012c
EUDAMED
IVD GeneralActive
Cardiac Troponin I FIA Test (Whole blood/Serum/Plasma) CTNI-4012F
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit MP-4022/MP-4021/MP-3022/MP-3021
EUDAMED
IVD GeneralActive
Cardiac Troponin I FIA Test (Serum/Plasma) CTNI-3012F
EUDAMED
IVD GeneralActive
Phencyclidine(PCP) Rapid Test(Urine) PCP-1011/PCP-1012/PCP-1014
EUDAMED
IVD GeneralActive
GHB Rapid Test(Urine) GHB-1011/GHB-1012/GHB-1014
EUDAMED
IVD GeneralActive
6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva) 6-MAM-7011/6-MAM-7012/6-MAM-7014/6-MAM-7015
EUDAMED
IVD GeneralActive
Malaria P.v. Rapid Test (Whole Blood) MAL-4011b/MAL-4012b
EUDAMED
IVD GeneralActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.