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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 (335)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Herpes simplex virus(HSV) IgG/IgM Rapid Test (Serum/Plasma) | HSV-3022 | EUDAMED | IVD General | Active |
| Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) | FSH-1011/FSH-1012/FSH-1013 | EUDAMED | IVD General | Active |
| BV pH Rapid Test | PH-6011/PH-6012 | EUDAMED | IVD General | Active |
| COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab) | FCRAM-6062 | EUDAMED | IVD General | Active |
| Acetaminophen(ACE) Rapid Test | ACE-1011/ACE-1012/ACE-1014/ACE-7012/ACE-7014 | EUDAMED | IVD General | Active |
| Methylenedioxypyrovalerone(MDPV) Rapid Test(Urine) | MDPV-1011/MDPV-1012/MDPV-1014 | EUDAMED | IVD General | Active |
| 6-Monoacetylmorphine(6-MAM) Rapid Test(Urine) | 6-MAM-1011/6-MAM-1012/6-MAM-1014 | EUDAMED | IVD General | Active |
| D-Dimer Rapid Test Kit(Whole Blood/plasma) | DIM-4012 | EUDAMED | IVD General | Active |
| Luteinizing Hormone(LH) Rapid Test Kit (Urine) | LH-1011/LH-1012/LH-1013 | EUDAMED | IVD General | Active |
| Zopiclone(ZOP) Rapid Test(Urine) | ZOP-1011/ZOP-1012/ZOP-1014 | EUDAMED | IVD General | Active |
| Acetaminophen(ACE) Rapid Test(Urine) | ACE-1011/ACE-1012/ACE-1014 | EUDAMED | IVD General | Active |
| Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma) | CTNI-4012 | EUDAMED | IVD General | Active |
| Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | LEI-4021/LEI-4022 | EUDAMED | IVD General | Active |
| Malaria P.v./Pan Rapid Test (Whole Blood) | MAL-4022c | EUDAMED | IVD General | Active |
| Marijuana(THC) Rapid Test Kit(Urine) | THC-1011/THC-1012/THC-1014 | EUDAMED | IVD General | Active |
| Synthetic Cannabis(K2) Rapid Test (Urine) | K2-1011/K2-1012/K2-1014 | EUDAMED | IVD General | Active |
| Cotinine(COT) Rapid Test Kit(Saliva) | COT-7012/COT-7014 | EUDAMED | IVD General | Active |
| Methcathinone(MCAT) Rapid Test(Urine) | MCAT-1011/MCAT-1012/MCAT-1014 | EUDAMED | IVD General | Active |
| BV pH Rapid Test Kit | PH-6011/PH-6012 | EUDAMED | IVD General | Active |
| Cocaine(COC) Rapid Test Kit(Urine) | COC-1011/COC-1012/COC-1014 | EUDAMED | IVD General | Active |
| Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma) | RV-3022 | EUDAMED | IVD General | Active |
| Phosphorylated Tau-181 Protein Rapid Test(Serum/Plasma) | Tau181-3011/Tau181-3012 | EUDAMED | IVD General | Active |
| Opiate(OPI) Rapid Test Kit(Urine) | OPI-1011/OPI-1012/OPI-1014 | EUDAMED | IVD General | Active |
| Phencyclidine(PCP) Rapid Test Kit (Urine) | PCP-1011/PCP-1012/PCP-1014 | EUDAMED | IVD General | Active |
| Creatine Kinase-MB Rapid Test (Whole Blood/Serum/Plasma) | CKMB-4012 | EUDAMED | IVD General | Active |
| Synthetic Cannabis Rapid Test(Saliva) | K2-7011/K2-7012/K2-7014 | EUDAMED | IVD General | Active |
| Carisoprodol(SOMA) Rapid Test(Saliva) | SOMA-7011/SOMA-7012/SOMA-7014/SOMA-7015 | EUDAMED | IVD General | Active |
| Myoglobin FIA Test (Whole blood/Serum/Plasma) | MYO-4012F | EUDAMED | IVD General | Active |
| Pregabalin Rapid Test(Urine) | PGB-1011/PGB-1012/PGB-1014 | EUDAMED | IVD General | Active |
| Monkeypox Virus Antigen Rapid Test(Swab) | MON Ag-6012 | EUDAMED | IVD General | Active |
| SP10 Protein Rapid Test(Semen) | SP10-6012 | EUDAMED | IVD General | Active |
| Gonorrhoea Rapid Test Kit(Swab) | GON-6012 | EUDAMED | IVD General | Active |
| Urine Adulteration Test (Urine) | ADU-1061 | EUDAMED | IVD General | Active |
| Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma) | RV-4022 | EUDAMED | IVD General | Active |
| Interleukin-6 FIA Test (Serum/Plasma) | 6IL-3012F | EUDAMED | IVD General | Active |
| MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma) | CKMB-3012F | EUDAMED | IVD General | Active |
| Alcohol Rapid Test Kit(Milk) | ALC-8011/ALC-8014 | EUDAMED | IVD General | Active |
| Respiratory Pathogens Antigen Combo Rapid Test | MID-6142 | EUDAMED | IVD General | Active |
| Pregabalin(PGB)Rapid Test(Urine) | PGB-1011/PGB-1012/PGB-1014 | EUDAMED | IVD General | Active |
| Oxycodone(OXY) Rapid Test (Urine) | OXY-1011/OXY-1012/OXY-1014 | EUDAMED | IVD General | Active |
| Cardiac Markers Combo Rapid Test (Serum/Plasma) (CTNI/CKMB/MYO) | CMC-3032a | EUDAMED | IVD General | Active |
| Micro-Albumin Rapid Test(Urine) | ALB-1011/ALB-1012/ALB-1014 | EUDAMED | IVD General | Active |
| Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma) | HAV-4012/HAV-4022/HAV-3012/HAV-3022 | EUDAMED | IVD General | Active |
| Cardiac Troponin I(CTNI) Rapid Test (Whole Blood/Serum/Plasma) | CTNI-4012 | EUDAMED | IVD General | Active |
| Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B | FCO-6032H | EUDAMED | IVD devices for self-testing | Active |
| HCG Pregnancy Rapid Test(Urine) | HCG-1011/HCG-1012/HCG-1013 | EUDAMED | IVD General | Active |
| Tramadol(TML) Rapid Test(Urine) | TML-1011/TML-1012/TML-1014 | EUDAMED | IVD General | Active |
| Ethylglucoronide(ETG) Rapid Test Kit(Urine) | ETG-1011/ETG-1012/ETG-1014 | EUDAMED | IVD General | Active |
| Marijuana(THC) Rapid Test(Saliva) | THC-7011/THC-7012/THC-7014/THC-7015 | EUDAMED | IVD General | Active |
| H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) | HPAb-4011/HPAb-4012 | EUDAMED | IVD General | Active |
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