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 (335)

Page 1 of 7
DeviceModel / ReferenceRegistriesClassStatus
Herpes simplex virus(HSV) IgG/IgM Rapid Test (Serum/Plasma) HSV-3022
EUDAMED
IVD GeneralActive
Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) FSH-1011/FSH-1012/FSH-1013
EUDAMED
IVD GeneralActive
BV pH Rapid Test PH-6011/PH-6012
EUDAMED
IVD GeneralActive
COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab) FCRAM-6062
EUDAMED
IVD GeneralActive
Acetaminophen(ACE) Rapid Test ACE-1011/ACE-1012/ACE-1014/ACE-7012/ACE-7014
EUDAMED
IVD GeneralActive
Methylenedioxypyrovalerone(MDPV) Rapid Test(Urine) MDPV-1011/MDPV-1012/MDPV-1014
EUDAMED
IVD GeneralActive
6-Monoacetylmorphine(6-MAM) Rapid Test(Urine) 6-MAM-1011/6-MAM-1012/6-MAM-1014
EUDAMED
IVD GeneralActive
D-Dimer Rapid Test Kit(Whole Blood/plasma) DIM-4012
EUDAMED
IVD GeneralActive
Luteinizing Hormone(LH) Rapid Test Kit (Urine) LH-1011/LH-1012/LH-1013
EUDAMED
IVD GeneralActive
Zopiclone(ZOP) Rapid Test(Urine) ZOP-1011/ZOP-1012/ZOP-1014
EUDAMED
IVD GeneralActive
Acetaminophen(ACE) Rapid Test(Urine) ACE-1011/ACE-1012/ACE-1014
EUDAMED
IVD GeneralActive
Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma) CTNI-4012
EUDAMED
IVD GeneralActive
Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) LEI-4021/LEI-4022
EUDAMED
IVD GeneralActive
Malaria P.v./Pan Rapid Test (Whole Blood) MAL-4022c
EUDAMED
IVD GeneralActive
Marijuana(THC) Rapid Test Kit(Urine) THC-1011/THC-1012/THC-1014
EUDAMED
IVD GeneralActive
Synthetic Cannabis(K2) Rapid Test (Urine) K2-1011/K2-1012/K2-1014
EUDAMED
IVD GeneralActive
Cotinine(COT) Rapid Test Kit(Saliva) COT-7012/COT-7014
EUDAMED
IVD GeneralActive
Methcathinone(MCAT) Rapid Test(Urine) MCAT-1011/MCAT-1012/MCAT-1014
EUDAMED
IVD GeneralActive
BV pH Rapid Test Kit PH-6011/PH-6012
EUDAMED
IVD GeneralActive
Cocaine(COC) Rapid Test Kit(Urine) COC-1011/COC-1012/COC-1014
EUDAMED
IVD GeneralActive
Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma) RV-3022
EUDAMED
IVD GeneralActive
Phosphorylated Tau-181 Protein Rapid Test(Serum/Plasma) Tau181-3011/Tau181-3012
EUDAMED
IVD GeneralActive
Opiate(OPI) Rapid Test Kit(Urine) OPI-1011/OPI-1012/OPI-1014
EUDAMED
IVD GeneralActive
Phencyclidine(PCP) Rapid Test Kit (Urine) PCP-1011/PCP-1012/PCP-1014
EUDAMED
IVD GeneralActive
Creatine Kinase-MB Rapid Test (Whole Blood/Serum/Plasma) CKMB-4012
EUDAMED
IVD GeneralActive
Synthetic Cannabis Rapid Test(Saliva) K2-7011/K2-7012/K2-7014
EUDAMED
IVD GeneralActive
Carisoprodol(SOMA) Rapid Test(Saliva) SOMA-7011/SOMA-7012/SOMA-7014/SOMA-7015
EUDAMED
IVD GeneralActive
Myoglobin FIA Test (Whole blood/Serum/Plasma) MYO-4012F
EUDAMED
IVD GeneralActive
Pregabalin Rapid Test(Urine) PGB-1011/PGB-1012/PGB-1014
EUDAMED
IVD GeneralActive
Monkeypox Virus Antigen Rapid Test(Swab) MON Ag-6012
EUDAMED
IVD GeneralActive
SP10 Protein Rapid Test(Semen) SP10-6012
EUDAMED
IVD GeneralActive
Gonorrhoea Rapid Test Kit(Swab) GON-6012
EUDAMED
IVD GeneralActive
Urine Adulteration Test (Urine) ADU-1061
EUDAMED
IVD GeneralActive
Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma) RV-4022
EUDAMED
IVD GeneralActive
Interleukin-6 FIA Test (Serum/Plasma) 6IL-3012F
EUDAMED
IVD GeneralActive
MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma) CKMB-3012F
EUDAMED
IVD GeneralActive
Alcohol Rapid Test Kit(Milk) ALC-8011/ALC-8014
EUDAMED
IVD GeneralActive
Respiratory Pathogens Antigen Combo Rapid Test MID-6142
EUDAMED
IVD GeneralActive
Pregabalin(PGB)Rapid Test(Urine) PGB-1011/PGB-1012/PGB-1014
EUDAMED
IVD GeneralActive
Oxycodone(OXY) Rapid Test (Urine) OXY-1011/OXY-1012/OXY-1014
EUDAMED
IVD GeneralActive
Cardiac Markers Combo Rapid Test (Serum/Plasma) (CTNI/CKMB/MYO) CMC-3032a
EUDAMED
IVD GeneralActive
Micro-Albumin Rapid Test(Urine) ALB-1011/ALB-1012/ALB-1014
EUDAMED
IVD GeneralActive
Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma) HAV-4012/HAV-4022/HAV-3012/HAV-3022
EUDAMED
IVD GeneralActive
Cardiac Troponin I(CTNI) Rapid Test (Whole Blood/Serum/Plasma) CTNI-4012
EUDAMED
IVD GeneralActive
Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B FCO-6032H
EUDAMED
IVD devices for self-testingActive
HCG Pregnancy Rapid Test(Urine) HCG-1011/HCG-1012/HCG-1013
EUDAMED
IVD GeneralActive
Tramadol(TML) Rapid Test(Urine) TML-1011/TML-1012/TML-1014
EUDAMED
IVD GeneralActive
Ethylglucoronide(ETG) Rapid Test Kit(Urine) ETG-1011/ETG-1012/ETG-1014
EUDAMED
IVD GeneralActive
Marijuana(THC) Rapid Test(Saliva) THC-7011/THC-7012/THC-7014/THC-7015
EUDAMED
IVD GeneralActive
H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) HPAb-4011/HPAb-4012
EUDAMED
IVD GeneralActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.