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