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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 4 of 7
DeviceModel / ReferenceRegistriesClassStatus
Alcohol Rapid Test(Urine) ALC-1011/ALC-1012/ALC-1014
EUDAMED
IVD GeneralActive
Methadone(MTD) Rapid Test (Urine) MTD-1011/MTD-1012/MTD-1014
EUDAMED
IVD GeneralActive
Propoxyphene(PPX) Rapid Test (Urine) PPX-1011/PPX-1012/PPX-1014
EUDAMED
IVD GeneralActive
Zopiclone(ZOP) Rapid Test(Saliva) ZOP-7011/ZOP-7012/ZOP-7014/ZOP-7015
EUDAMED
IVD GeneralActive
Propoxyphene(PPX) Rapid Test Kit(Urine) PPX-1011/PPX-1012/PPX-1014
EUDAMED
IVD GeneralActive
Strep A Rapid Test Kit (swab) STA-6011/STA-6012
EUDAMED
IVD GeneralActive
Bacterial Vaginosis Multi-Test(Swab) MAV-6022/MVA-6032/MVA-6042/MVA-6052
EUDAMED
IVD GeneralActive
Cannabidiol Rapid Test(Urine) CBD-1011/CBD-1012/CBD-1014
EUDAMED
IVD GeneralActive
Procalcitonin FIA Test (Whole blood/Serum/Plasma) PCT-4012F
EUDAMED
IVD GeneralActive
Methadone(MTD) Rapid Test Kit(Urine) MTD-1011/MTD-1012/MTD-1014
EUDAMED
IVD GeneralActive
Methamphetamine(MET) Rapid Test (Urine) MET-1011/MET-1012/MET-1014
EUDAMED
IVD GeneralActive
Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma) TB-4011/TB-4012
EUDAMED
IVD GeneralActive
Methylenedioxypyrovalerone(MDPV) Rapid Test(Saliva) MDPV-7011/MDPV-7012/MDPV-7014/MDPV-7015
EUDAMED
IVD GeneralActive
Chagas Rapid Test (WB/S/P) CHA-4011/CHA-4012
EUDAMED
IVD GeneralActive
Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) (CTNI/CKMB/MYB) CMC-4032a
EUDAMED
IVD GeneralActive
Gonorrhoea Rapid Test(Swab) GON-6012
EUDAMED
IVD GeneralActive
Malaria P.f./P.v. Rapid Test Kit(Whole Blood) MAL-4022a
EUDAMED
IVD GeneralActive
Human AD7c-NTP Rapid Test(Urine) AD7c-1011/AD7c-1012
EUDAMED
IVD GeneralActive
Barbiturates(BAR) Rapid Test (Urine) BAR-1011/BAR-1012/BAR-1014
EUDAMED
IVD GeneralActive
Fecal Occult Blood FIA Test (Feces) FOB-5012F
EUDAMED
IVD GeneralActive
D-Dimer FIA Test (Whole blood/Plasma) DIM-4012F
EUDAMED
IVD GeneralActive
Kratom(KRA) Rapid Test (Urine) KRA-1011/KRA-1012/KRA-1014
EUDAMED
IVD GeneralActive
Fecal Occult Blood(FOB) Rapid Test (Feces) FOB-5011/FOB-5012
EUDAMED
IVD GeneralActive
Dengue IgG/IgM Rapid Test (Serum/Plasma) DEN-3022
EUDAMED
IVD GeneralActive
Phosphorylated Tau-217 Protein Rapid Test(Serum/Plasma) Tau217-3011/Tau217-3012
EUDAMED
IVD GeneralActive
SP10 Protein Rapid Test SP10-6012
EUDAMED
IVD GeneralActive
Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma) HSV-4022
EUDAMED
IVD GeneralActive
Codeine(COD) Rapid Test COD-1011/COD-1012/COD-1014/COD-7012/COD-7014
EUDAMED
IVD GeneralActive
Monkeypox Virus Antigen Rapid Test(Serum/Plasma) MON Ag-3012
EUDAMED
IVD GeneralActive
Interleukin-6 FIA Test (Whole blood/Serum/Plasma) 6IL-4012F
EUDAMED
IVD GeneralActive
Influenza A/B Antigen FIA Test (Swab) FLU-6012F
EUDAMED
IVD GeneralActive
Ecstasy(MDMA) Rapid Test Kit(Urine) MDMA-1011/MDMA-1012/MDMA-1014
EUDAMED
IVD GeneralActive
MB Isoenzyme of Creatine Kinase FIA Test (Whole blood/Serum/Plasma) CKMB-4012F
EUDAMED
IVD GeneralActive
H.pylori Antigen Rapid Test (Feces) HPAg-5011/HPAg-5012
EUDAMED
IVD GeneralActive
Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma) HAV-3012
EUDAMED
IVD GeneralActive
Buprenorphine(BUP) Rapid Test Kit(Urine) BUP-1011/BUP-1012/BUP-1014
EUDAMED
IVD GeneralActive
Human Chorionic Gonadotropin(HCG) Rapid Test (Urine/Serum) HCG-2011/HCG-2012
EUDAMED
IVD GeneralActive
Luteinizing Hormone(LH) Rapid Test (Urine) LH-1011/LH-1012/LH-1013
EUDAMED
IVD GeneralActive
Dengue NS1 Rapid Test (Serum/Plasma) DEN-3012
EUDAMED
IVD GeneralActive
Amyloid β-protein(Aβ) Rapid Test (Whole Blood/Serum/Plasma) ABP-4011/ABP-4012
EUDAMED
IVD GeneralActive
Urine Analysis Test Strip(Urine) URS-1111
EUDAMED
IVD GeneralActive
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

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