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Sign in to claim this brandSafecare 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
- Website
- safecare.com.cn
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Selina Zhang
- EUDAMED SRN
- CN-MF-000019109
- FDA FEI Number
- —
- DUNS Number
- 544349634
Catalogue (342)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alcohol Rapid Test(Urine) | ALC-1011/ALC-1012/ALC-1014 | EUDAMED | IVD General | Active |
| Methadone(MTD) Rapid Test (Urine) | MTD-1011/MTD-1012/MTD-1014 | EUDAMED | IVD General | Active |
| Propoxyphene(PPX) Rapid Test (Urine) | PPX-1011/PPX-1012/PPX-1014 | EUDAMED | IVD General | Active |
| Zopiclone(ZOP) Rapid Test(Saliva) | ZOP-7011/ZOP-7012/ZOP-7014/ZOP-7015 | EUDAMED | IVD General | Active |
| Propoxyphene(PPX) Rapid Test Kit(Urine) | PPX-1011/PPX-1012/PPX-1014 | EUDAMED | IVD General | Active |
| Strep A Rapid Test Kit (swab) | STA-6011/STA-6012 | EUDAMED | IVD General | Active |
| Bacterial Vaginosis Multi-Test(Swab) | MAV-6022/MVA-6032/MVA-6042/MVA-6052 | EUDAMED | IVD General | Active |
| Cannabidiol Rapid Test(Urine) | CBD-1011/CBD-1012/CBD-1014 | EUDAMED | IVD General | Active |
| Procalcitonin FIA Test (Whole blood/Serum/Plasma) | PCT-4012F | EUDAMED | IVD General | Active |
| Methadone(MTD) Rapid Test Kit(Urine) | MTD-1011/MTD-1012/MTD-1014 | EUDAMED | IVD General | Active |
| Methamphetamine(MET) Rapid Test (Urine) | MET-1011/MET-1012/MET-1014 | EUDAMED | IVD General | Active |
| Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma) | TB-4011/TB-4012 | EUDAMED | IVD General | Active |
| Methylenedioxypyrovalerone(MDPV) Rapid Test(Saliva) | MDPV-7011/MDPV-7012/MDPV-7014/MDPV-7015 | EUDAMED | IVD General | Active |
| Chagas Rapid Test (WB/S/P) | CHA-4011/CHA-4012 | EUDAMED | IVD General | Active |
| Cardiac Markers Combo Rapid Test (Whole Blood/Serum/Plasma) (CTNI/CKMB/MYB) | CMC-4032a | EUDAMED | IVD General | Active |
| Gonorrhoea Rapid Test(Swab) | GON-6012 | EUDAMED | IVD General | Active |
| Malaria P.f./P.v. Rapid Test Kit(Whole Blood) | MAL-4022a | EUDAMED | IVD General | Active |
| Human AD7c-NTP Rapid Test(Urine) | AD7c-1011/AD7c-1012 | EUDAMED | IVD General | Active |
| Barbiturates(BAR) Rapid Test (Urine) | BAR-1011/BAR-1012/BAR-1014 | EUDAMED | IVD General | Active |
| Fecal Occult Blood FIA Test (Feces) | FOB-5012F | EUDAMED | IVD General | Active |
| D-Dimer FIA Test (Whole blood/Plasma) | DIM-4012F | EUDAMED | IVD General | Active |
| Kratom(KRA) Rapid Test (Urine) | KRA-1011/KRA-1012/KRA-1014 | EUDAMED | IVD General | Active |
| Fecal Occult Blood(FOB) Rapid Test (Feces) | FOB-5011/FOB-5012 | EUDAMED | IVD General | Active |
| Dengue IgG/IgM Rapid Test (Serum/Plasma) | DEN-3022 | EUDAMED | IVD General | Active |
| Phosphorylated Tau-217 Protein Rapid Test(Serum/Plasma) | Tau217-3011/Tau217-3012 | EUDAMED | IVD General | Active |
| SP10 Protein Rapid Test | SP10-6012 | EUDAMED | IVD General | Active |
| Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma) | HSV-4022 | EUDAMED | IVD General | Active |
| Codeine(COD) Rapid Test | COD-1011/COD-1012/COD-1014/COD-7012/COD-7014 | EUDAMED | IVD General | Active |
| Monkeypox Virus Antigen Rapid Test(Serum/Plasma) | MON Ag-3012 | EUDAMED | IVD General | Active |
| Interleukin-6 FIA Test (Whole blood/Serum/Plasma) | 6IL-4012F | EUDAMED | IVD General | Active |
| Influenza A/B Antigen FIA Test (Swab) | FLU-6012F | EUDAMED | IVD General | Active |
| Ecstasy(MDMA) Rapid Test Kit(Urine) | MDMA-1011/MDMA-1012/MDMA-1014 | EUDAMED | IVD General | Active |
| MB Isoenzyme of Creatine Kinase FIA Test (Whole blood/Serum/Plasma) | CKMB-4012F | EUDAMED | IVD General | Active |
| H.pylori Antigen Rapid Test (Feces) | HPAg-5011/HPAg-5012 | EUDAMED | IVD General | Active |
| Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma) | HAV-3012 | EUDAMED | IVD General | Active |
| Buprenorphine(BUP) Rapid Test Kit(Urine) | BUP-1011/BUP-1012/BUP-1014 | EUDAMED | IVD General | Active |
| Human Chorionic Gonadotropin(HCG) Rapid Test (Urine/Serum) | HCG-2011/HCG-2012 | EUDAMED | IVD General | Active |
| Luteinizing Hormone(LH) Rapid Test (Urine) | LH-1011/LH-1012/LH-1013 | EUDAMED | IVD General | Active |
| Dengue NS1 Rapid Test (Serum/Plasma) | DEN-3012 | EUDAMED | IVD General | Active |
| Amyloid β-protein(Aβ) Rapid Test (Whole Blood/Serum/Plasma) | ABP-4011/ABP-4012 | EUDAMED | IVD General | Active |
| Urine Analysis Test Strip(Urine) | URS-1111 | EUDAMED | IVD General | Active |
| Chagas Rapid Test (Whole Blood/Serum/Plasma) | CHA-4011/CHA-4012 | EUDAMED | IVD General | Active |
| Cholera O1 Antigen Rapid Test | CHO-5012 | EUDAMED | IVD General | Active |
| Myoglobin Rapid Test (Serum/Plasma) | MYO-3012 | EUDAMED | IVD General | Active |
| Barbiturates(BAR) Rapid Test Kit(Urine) | BAR-1011/BAR-1012/BAR-1014 | EUDAMED | IVD General | Active |
| Ecstasy(MDMA) Rapid Test (Saliva) | MDMA-7011/MDMA-7012/MDMA-7014/MDMA-7015 | EUDAMED | IVD General | Active |
| Monkeypox Virus Antigen Rapid Test | MON Ag-4012/MON Ag-3012/MON Ag-6012 | EUDAMED | IVD General | Active |
| Cocaine(COC) Rapid Test(Saliva) | COC-7011/COC-7012/COC-7014/COC-7015 | EUDAMED | IVD General | Active |
| Rotavirus-Adenovirus-Astrovirus Combo Rapid Test (Feces) | MID-5032b | EUDAMED | IVD General | Active |
| Methylenedioxypyrovalerone(MDPV) Rapid Test | MDPV-1011/MDPV-1012/MDPV-1014/MDPV-7012/MDPV-7014 | EUDAMED | IVD General | Active |
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