Safecare Biotech(Hangzhou)Co., Ltd.
Manufacturer and brand owner in Huzhou, Zhejiang, China. 22 device types, 35 products catalogued, 9 clearances.
Safecare Biotech(Hangzhou)Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Paper, Obstetric Ph, Test, Urine Leukocyte and 20 other device types. 35 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
22device types registered with the FDA
35products catalogued under its own name
9510(k) clearances
Registration
| Registered name | SAFECARE BIOTECH(HANGZHOU)CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013077867 |
| FEI number | 3013077867 |
| DUNS | 544349634 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州赛凯生物技术有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Huzhou |
|---|---|
| Province | Zhejiang |
| Address | No.689, Changxing Avenue, Taihu Street, |
| Postal code | 313100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | Safecare Urinary Tract Infection Test | 2025 | 14 |
| Enzyme Immunoassay, Amphetamine | Class 2 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Marijuana, SAFECARE Urine Test Cocaine | 2016 | 16 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Marijuana, SAFECARE Urine Test Cocaine | 2016 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Marijuana, SAFECARE Urine Test Cocaine | 2016 | 16 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | hCG Urine Test Midstream, hCG Urine Test Strip, hCG Urine Test Cassette | 2020 | 30 |
| Paper, Obstetric Ph | Class 1 | Safecare Vaginal PH Rapid Test Cassette, TTestahead Vaginal PH Rapid Test Cassette, Firstview Vaginal PH Rapid Test Cassette, 2San Vaginal pH Rapid Test Cassette, Exploro Vaginal Health pH Test Device, WelCheck Vaginal pH Rapid Test Cassette and 2 more | 2023 | 13 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | SAFECARE COT Urine Cassette Test, SAFECARE COT Saliva Cassette Test, SAFECARE COT Urine Strip Test, SAFECARE COT Saliva Dip Card Test, SAFECARE COT Saliva Cup Test, SAFECARE COT Urine Dip card Test and 26 more | 2022 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 2 more | 2018 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | Unicare FSH Rapid Test Strip(Urine), TTestahead FSH Rapid Test Cassette(Urine), Firstview FSH Rapid Test Cassette(Urine), Firstview FSH Rapid Test Strip(Urine), Firstview FSH Rapid Test Midstream(Urine), Safecare FSH Rapid Test Strip(Urine) and 9 more | 2024 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Cubtale Ovulation (LH) Test Strip, SAFECARE Luteinizing Hormone Rapid Test Strip, SAFECARE Luteinizing Hormone Rapid Test Device, SAFECARE Luteinizing Hormone Rapid Test Midstream, FIRSTVIEW Luteinizing Hormone Rapid Test Strip, Wholesome Story Ovulation(LH) Test Strip and 11 more | 2019 | 38 |
| Test, Methadone, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Morphine, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 4 |
| Test, Opiates, Over The Counter | Class 2 | FIRSTVIEW FYL Urine Test Cassette, Safecare FYL Urine Test Cassette, FIRSTVIEW Fentanyl Urine Test Cassette, Safecare Fentanyl Urine Test Cassette, SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard and 5 more | 2018 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 12 |
| Test, Propoxyphene, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test DipCard, SAFECARE Multi-Drug Urine Test Dip Card, Safecare EDDP Urine Test Dipcard, Safecare OXY Urine Test Dipcard, Safecare BUP Urine Test Dipcard and 1 more | 2018 | 16 |
| Test, Urine Leukocyte | Class 1 | Safecare Urinary Tract Infection Test, Firstview urinary tract infection Test, Ttestahead urinary tract infection Test, WelCheck Urinary Tract Infection Test | 2023 | 16 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242767 | 2025-01-10 | JMT | Traditional | This company |
| K240654 | 2024-04-10 | NGL | Traditional | This company |
| K202453 | 2021-03-24 | NFT | Traditional | This company |
| K200133 | 2020-08-13 | LCX | Traditional | This company |
| K201120 | 2020-05-27 | NFT | Traditional | This company |
| K191924 | 2019-08-16 | NFW | Traditional | This company |
| K182654 | 2018-11-19 | NGG | Traditional | This company |
| K181968 | 2018-08-20 | NFT | Traditional | This company |
| K153646 | 2016-03-18 | DIO | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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