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

Catalogue (342)

Page 3 of 7
DeviceModel / ReferenceRegistriesClassStatus
Codeine(COD) Rapid Test(Urine) COD-1011/COD-1012/COD-1014
EUDAMED
IVD GeneralActive
Syphilis Rapid Test (Serum/Plasma) SYP-3011/SYP-4011
EUDAMED
IVD GeneralActive
Rotavirus Antigen Rapid Test(Feces) ROT-5011/ROT-5012
EUDAMED
IVD GeneralActive
Bacterial Vaginosis Multi-Test Kit MAV-6022/MVA-6032/MVA-6042/MVA-6052
EUDAMED
IVD GeneralActive
Rotavirus-Adenovirus Combo Rapid Test (Feces) ROT-5022
EUDAMED
IVD GeneralActive
COVID-19 IgG/IgM FIA Test (Serum/Plasma) COV Ab-3012F
EUDAMED
IVD GeneralActive
Benzodiazepine(BZO) Rapid Test (Urine) BZO-1011/BZO-1012/BZO-1014
EUDAMED
IVD GeneralActive
Phosphorylated Tau-181 Protein Rapid Test Tau181-4011/Tau181-3011/Tau181-4012/Tau181-3012
EUDAMED
IVD GeneralActive
Opiate(OPI) Rapid Test(Urine) OPI-1011/OPI-1012/OPI-1014
EUDAMED
IVD GeneralActive
Morphine Heroin(MOR) Rapid Test (Urine) MOP-1011/MOP-1012/MOP-1014
EUDAMED
IVD GeneralActive
Methaqualone(MQL) Rapid Test Kit(Urine) MQL-1011/MQL-1012/MQL-1014
EUDAMED
IVD GeneralActive
Buprenorphine(BUP) Rapid Test (Urine) BUP-1011/BUP-1012/BUP-1014
EUDAMED
IVD GeneralActive
Adenovirus Rapid Test (Feces) ADV-5011/ADV-5012
EUDAMED
IVD GeneralActive
Tuberculosis Rapid Test (Serum/Plasma) TB-3011/TB-3012
EUDAMED
IVD GeneralActive
Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma) LEI-3021/LEI-3022
EUDAMED
IVD GeneralActive
Hantavirus Rapid Test(WB/S/P) HV-4012
EUDAMED
IVD GeneralActive
Marijuana(THC) FIA Test (Urine) THC-1012F
EUDAMED
IVD GeneralActive
Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) FCO-6032
EUDAMED
IVD GeneralActive
Brucella IgG/IgM Rapid Test(WB/S/P) Bru-4022
EUDAMED
IVD GeneralActive
Ketamine(KET) Rapid Test(Urine) KET-1011/KET-1012/KET-1014
EUDAMED
IVD GeneralActive
Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) HAV-4022
EUDAMED
IVD GeneralActive
Norovirus Antigen FIA Test (Feces) NORO-5012F
EUDAMED
IVD GeneralActive
Etomidate Rapid Test(Urine) ETO-1011/ETO-1012/ETO-1014
EUDAMED
IVD GeneralActive
Methamphetamine(MET) Rapid Test Kit(Urine) MET-1011/MET-1012/MET-1014
EUDAMED
IVD GeneralActive
Herpes simplex virus(HSV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) HSV-4022
EUDAMED
IVD GeneralActive
Alcohol Rapid Test(Saliva) ALC-7011/ALC-7012/ALC-7014
EUDAMED
IVD GeneralActive
Alcohol Rapid Test Kit(Saliva) ALC-7011/ALC-7014
EUDAMED
IVD GeneralActive
Fentanyl(FYL) Rapid Test Kit(Urine) FYL-1011/FYL-1012/FYL-1014
EUDAMED
IVD GeneralActive
Strep B Rapid Test (Swab) STB-6011/STB-6012
EUDAMED
IVD GeneralActive
Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma) TYP-4022
EUDAMED
IVD GeneralActive
Alcohol Rapid Test Kit(Urine) ALC-1011/ALC-1012/ALC-1014
EUDAMED
IVD GeneralActive
Phosphorylated Tau-181 Protein Rapid Test(Whole blood/Serum/Plasma) Tau181-4011/Tau181-4012
EUDAMED
IVD GeneralActive
Tramadol(TML) Rapid Test Kit(Urine) TML-1011/TML-1012/TML-1014
EUDAMED
IVD GeneralActive
D-Dimer Rapid Test(Plasma) DIM-3012
EUDAMED
IVD GeneralActive
RSV Antigen Rapid Test(Swab) RSV-6011/RSV-6012
EUDAMED
IVD GeneralActive
Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma) DEN-3022
EUDAMED
IVD GeneralActive
Ketamine(KET) Rapid Test Kit(Urine) KET-1011/KET-1012/KET-1014
EUDAMED
IVD GeneralActive
Chagas Rapid Test (Serum/Plasma) CHA-3011/CHA-3012
EUDAMED
IVD GeneralActive
Methadone metabolite(EDDP) Rapid Test(Urine) EDDP-1011/EDDP-1012/EDDP-1014
EUDAMED
IVD GeneralActive
Carisoprodol(SOMA) Rapid Test SOMA-1011/SOMA-1012/SOMA-1014/SOMA-7012/SOMA-7014
EUDAMED
IVD GeneralActive
S.Typhi Antigen Rapid Test (Feces) TYP Ag-5012
EUDAMED
IVD GeneralActive
Gabapentin(GAB) Rapid Test(Urine) GAB-1011/GAB-1012/GAB-1014
EUDAMED
IVD GeneralActive
S.Typhi(TYP) Antigen Rapid Test (Feces) TYP Ag-5012
EUDAMED
IVD GeneralActive
Procalcitonin FIA Test (Serum/Plasma) PCT-3012F
EUDAMED
IVD GeneralActive
Alcohol Rapid Test(Milk) ALC-8011/ALC-8012/ALC-8014
EUDAMED
IVD GeneralActive
Gabapentin(GAB) Rapid Test GAB-1011/GAB-1012/GAB-1014/GAB-7012/GAB-7014
EUDAMED
IVD GeneralActive
Urine Analysis Test (Urine) URS-1**1
EUDAMED
IVD GeneralActive
Ecstasy(MDMA) Rapid Test (Urine) MDMA-1011/MDMA-1012/MDMA-1014
EUDAMED
IVD GeneralActive
Myoglobin Rapid Test(WB/S/P) MYO-4012
EUDAMED
IVD GeneralActive
Monkeypox Virus IgG/IgM Rapid Test(Serum/Plasma) MON Ab-3022
EUDAMED
IVD GeneralActive

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