FDA Registration
Active
🇨🇳 China
SAFECARE Multi-Drug Urine Test Cup
Reg #: 3013077867
·
FEI: 3013077867
·
Expires 2025
Products
12
Proprietary Names
2
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- SAFECARE BIOTECH(HANGZHOU)CO.,LTD
- Registration Number
- 3013077867
- FEI Number
- 3013077867
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 2/203, No. 18 Haishu Road, Cangqian Sub-district,Yuhang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182654
Owner / Operator
- Firm Name
- Safecare Biotech(Hangzhou)Co.,Ltd
- Operator Number
- 10052102
- Address
- Building 2/203 No.18 Haishu Rd.,, Cangqian Sub-district,Yuhang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- Alex Qiu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2018-11-28 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2018-11-28 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2018-11-28 |
Proprietary Names
SAFECARE Multi-Drug Urine Test Cup
SAFECARE Multi-Drug Urine Test DipCard
Establishment Types
Manufacture Medical Device