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