FDA Registration
Active
🇨🇳 China
Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx
Reg #: 3015821396
·
FEI: 3015821396
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- JCMED TIANJIN IMPORT AND EXPORT CO., LTD
- Registration Number
- 3015821396
- FEI Number
- 3015821396
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone
- City
- Tianjin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220685
Owner / Operator
- Firm Name
- JcMed TIANJIN Import and Export Co., Ltd
- Operator Number
- 10081379
- Address
- 418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone
- City
- Tianjin
- State
- CN-TJ
- Postal Code
- 300300
- Country
- CN
- Correspondent
- Allan Zhang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-05-18 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-05-18 |
Proprietary Names
Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx
Establishment Types
Export Device to the United States But Perform No Other Operation on Device