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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 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
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
Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma) MON Ab-4022
EUDAMED
IVD GeneralActive
Malaria P.f. Rapid Test Kit(Whole Blood) MAL-4011/MAL-4012a
EUDAMED
IVD GeneralActive
Rotavirus-Adenovirus Combo Rapid Test Kit(Feces) ROT-5022
EUDAMED
IVD GeneralActive
Methylphenidate(MPD) Rapid Test MPD-1011/MPD-1012/MPD-1014/MPD-7012/MPD-7014
EUDAMED
IVD GeneralActive
Phosphorylated Tau-217 Protein Rapid Test(Whole blood/Serum/Plasma) Tau217-4011 Tau217-4012
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma) MP-3021/MP-3022
EUDAMED
IVD GeneralActive
Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma) MON Ag-4012
EUDAMED
IVD GeneralActive
Zaleplon(ZAL) Rapid Test(Urine) ZAL-1011/ZAL-1012/ZAL-1014
EUDAMED
IVD GeneralActive
Fentanyl(FYL) Rapid Test(Urine) FYL-1011/FYL-1012/FYL-1014
EUDAMED
IVD GeneralActive
Zopiclone(ZOP) Rapid Test ZOP-1011/ZOP-1012/ZOP-1014/ZOP-7012/ZOP-7014
EUDAMED
IVD GeneralActive
C-reactive protein FIA Test (Whole blood/Serum/Plasma) CRP-4012F
EUDAMED
IVD GeneralActive
Cocaine(COC) Rapid Test Kit(Saliva) COC-7012/COC-7014
EUDAMED
IVD GeneralActive
Amphetamine(AMP) Rapid Test (Urine) AMP-1011/AMP-1012/AMP-1014
EUDAMED
IVD GeneralActive
Zaleplon(ZAL) Rapid Test ZAL-1011/ZAL-1012/ZAL-1014/ZAL-7012/ZAL-7014
EUDAMED
IVD GeneralActive
Multi drug Rapid Urine Test MDD-1xx2/MDP-1xx4/MDC-1xx5
EUDAMED
IVD GeneralActive
Etomidate(ETO) Rapid Test(Urine) ETO-1011/ETO-1012/ETO-1014
EUDAMED
IVD GeneralActive
Codeine(COD) Rapid Test(Saliva) COD-7011/COD-7012/COD-7014/COD-7015
EUDAMED
IVD GeneralActive
Myoglobin FIA Test (Serum/Plasma) MYO-3012F
EUDAMED
IVD GeneralActive
Vaginitis Multi-Test(Swab) MVA-6**1C/MVA-6**2C
EUDAMED
IVD GeneralActive
Urine Adulteration(ADU) Test (Urine) ADU-1061
EUDAMED
IVD GeneralActive
Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) (CTNI/CKMB/MYO) CMC-4032a
EUDAMED
IVD GeneralActive
Cardiac Troponin I(CTNI) Rapid Test (Serum/Plasma) CTNI-3012
EUDAMED
IVD GeneralActive
GHB Rapid Test Kit(Urine) GHB-1011/GHB-1012/GHB-1014
EUDAMED
IVD GeneralActive
Marijuana(THC) Rapid Test Kit(Saliva) THC-7012/THC-7014
EUDAMED
IVD GeneralActive
Benzodiazepine(BZO) Rapid Test Kit(Urine) BZO-1011/BZO-1012/BZO-1014
EUDAMED
IVD GeneralActive
"Human Chorionic Gonadotropin(HCG) Rapid Test Kit(Urine/Serum)" HCG-2011/HCG-2012
EUDAMED
IVD GeneralActive
Synthetic Cannabis(K2) Rapid Test Kit(Urine) K2-1011/K2-1012/K2-1014
EUDAMED
IVD GeneralActive
HCG Rapid Test Kit (Urine) HCG-1011/HCG-1012/HCG-1013
EUDAMED
IVD GeneralActive
H.pylori Antigen FIA Test (Feces) HPAg -5012F
EUDAMED
IVD GeneralActive
Alpha Fetal Protein FIA Test (Serum/Plasma) AFP-3012F
EUDAMED
IVD GeneralActive
Oxycodone(OXY) Rapid Test Kit(Urine) OXY-1011/OXY-1012/OXY-1014
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Whole Blood/Serum/Plasma) MP-4021/MP-4022
EUDAMED
IVD GeneralActive
Prueba rápida combinada de antígenos de COVID-19/Gripe/VSR (Hisopo) FCR-6042
EUDAMED
IVD GeneralActive
Human AD7c-NTP Rapid Test AD7c-1011/AD7c-1012/AD7c-1014
EUDAMED
IVD GeneralActive
Gabapentin(GAB) Rapid Test(Saliva) GAB-7011/GAB-7012/GAB-7014/GAB-7015
EUDAMED
IVD GeneralActive
Methcathinone(MCAT) Rapid Test MCAT-1011/MCAT-1012/MCAT-1014/MCAT-7012/MCAT-7014
EUDAMED
IVD GeneralActive
RSV Antigen Rapid Test RSV-6011/ RSV-6012
EUDAMED
IVD GeneralActive
Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19) FCO-6032a/FCO-6032b
EUDAMED
IVD GeneralActive
Methadone metabolite(EDDP) Rapid Test Kit(Urine) EDDP-1011/EDDP-1012/EDDP-1014
EUDAMED
IVD GeneralActive
Zika IgM/IgG Rapid Test(Whole Blood/Serum/Plasma) ZIKA-4022
EUDAMED
IVD GeneralActive
Morphine Heroin(MOR) Rapid Test Kit(Urine) MOR-1011/MOR-1012/MOR-1014
EUDAMED
IVD GeneralActive
Methylphenidate(MPD) Rapid Test(Urine) MPD-1011/MPD-1012/MPD-1014
EUDAMED
IVD GeneralActive
Ethylglucoronide(ETG) Rapid Test (Urine) ETG-1011/ETG-1012/ETG-1014
EUDAMED
IVD GeneralActive

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