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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 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 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 |
| Cotinine(COT) Rapid Test(Saliva) | COT-7011/COT-7012/COT-7014/COT-7015 | EUDAMED | IVD General | Active |
| Cholera O1 Antigen Rapid Test(Feces) | CHO-5012 | EUDAMED | IVD General | Active |
| Lysergic acid diethylamide(LSD) Rapid Test Kit(Urine) | LSD-1011/LSD-1012/LSD-1014 | EUDAMED | IVD General | Active |
| Calprotectin Antigen Rapid Test (Feces) | CAL-5012 | EUDAMED | IVD General | Active |
| Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) | FCRA-6052 | EUDAMED | IVD General | Active |
| Strep B Rapid Test Kit (swab) | STB-6011/STB-6012 | EUDAMED | IVD General | Active |
| Phosphorylated Tau-217 Protein Rapid Test | Tau217-4011/Tau217-3011/Tau217-4012/Tau217-3012 | EUDAMED | IVD General | Active |
| Malaria P.f./Pan Rapid Test (Whole Blood) | MAL-4022b | EUDAMED | IVD General | Active |
| Cannabidiol(CBD)Rapid Test(Urine) | CBD-1011/CBD-1012/CBD-1014 | EUDAMED | IVD General | Active |
| Multi drug Rapid Saliva Test | MDD-7**2/MDP-7**3/MDC-7**5 | EUDAMED | IVD General | Active |
| Amphetamine(AMP) Rapid Test Kit(Urine) | AMP-1011/AMP-1012/AMP-1014 | EUDAMED | IVD General | Active |
| Acetaminophen(ACE) Rapid Test(Saliva) | ACE-7011/ACE-7012/ACE-7014/ACE-7015 | EUDAMED | IVD General | Active |
| Calprotein Rapid Test (Feces) | CAL-5012 | EUDAMED | IVD General | Active |
| Leishmaniasis Rapid Test (Whole Blood/serum/plasma) | LEI-4011/LEI-4012 | EUDAMED | IVD General | Active |
| Hantavirus IgG/IgM Rapid Test(WB/S/P) | HV-4022 | EUDAMED | IVD General | Active |
| Methylphenidate(MPD) Rapid Test(Saliva) | MPD-7011/MPD-7012/MPD-7014/MPD-7015 | EUDAMED | IVD General | Active |
| Brucella IgG/IgM Rapid Test (Serum/Plasma) | Bru-3022 | EUDAMED | IVD General | Active |
| Dengue NS1 Rapid Test Kit(Whole Blood/serum/plasma) | DEN-4012 | EUDAMED | IVD General | Active |
| Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal | COV Ag-6012H | EUDAMED | IVD devices for self-testing | Active |
| Multi drug Rapid Saliva Test | MDD-1xx2/MDP-1xx4/MDC-1xx5 | EUDAMED | IVD General | Active |
| Cotinine(COT) Rapid Test Kit (Urine) | COT-1011/COT-1012/COT-1014 | EUDAMED | IVD General | Active |
| COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test | FCRAhH-6082 | EUDAMED | IVD General | Active |
| Creatine Kinase-MB(CKMB) Rapid Test (Serum/Plasma) | CKMB-3012 | EUDAMED | IVD General | Active |
| Zika IgM/IgG Rapid Test(Serum/Plasma) | ZIKA-3022 | EUDAMED | IVD General | Active |
| Rotavirus Rapid Test (Feces) | ROT-5011/ROT-5012 | EUDAMED | IVD General | Active |
| Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma) | HAV-4012 | EUDAMED | IVD General | Active |
| Legionella & S.pneumoniae Antigen Combo Rapid Test(Urine) | MID-1022 | EUDAMED | IVD General | Active |
| Strep A Rapid Test (Swab) | STA-6011/STA-6012 | EUDAMED | IVD General | Active |
| Micro-Albumin Rapid Test Kit(Urine) | ALB-1011/ALB-1012/ALB-1014 | EUDAMED | IVD General | Active |
| H.pylori Antigen Rapid Test Kit(Feces) | HPAg-5011/HPAg-5012 | EUDAMED | IVD General | Active |
| Carisoprodol(SOMA) Rapid Test(Urine) | SOMA-1011/SOMA-1012/SOMA-1014 | EUDAMED | IVD General | Active |
| Methcathinone(MCAT) Rapid Test(Saliva) | MCAT-7011/MCAT-7012/MCAT-7014/MCAT-7015 | EUDAMED | IVD General | Active |
| Rotavirus-Adenovirus-Norovirus-Astrovirus Combo Rapid Test(Feces) | MID-5042 | EUDAMED | IVD General | Active |
| Malaria Pan Rapid Test (Whole Blood) | MAL-4011c/MAL-4012c | EUDAMED | IVD General | Active |
| Cardiac Troponin I FIA Test (Whole blood/Serum/Plasma) | CTNI-4012F | EUDAMED | IVD General | Active |
| Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit | MP-4022/MP-4021/MP-3022/MP-3021 | EUDAMED | IVD General | Active |
| Cardiac Troponin I FIA Test (Serum/Plasma) | CTNI-3012F | EUDAMED | IVD General | Active |
| Phencyclidine(PCP) Rapid Test(Urine) | PCP-1011/PCP-1012/PCP-1014 | EUDAMED | IVD General | Active |
| GHB Rapid Test(Urine) | GHB-1011/GHB-1012/GHB-1014 | EUDAMED | IVD General | Active |
| 6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva) | 6-MAM-7011/6-MAM-7012/6-MAM-7014/6-MAM-7015 | EUDAMED | IVD General | Active |
| Malaria P.v. Rapid Test (Whole Blood) | MAL-4011b/MAL-4012b | EUDAMED | IVD General | Active |
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