FDA Registration
Active
🇨🇳 China
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3025349997
·
FEI: 3025349997
·
Expires 2026
Products
13
Proprietary Names
18
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3025349997
- FEI Number
- 3025349997
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233624
Owner / Operator
- Firm Name
- Hangzhou Aichek Medical Technology Co., Ltd.
- Operator Number
- 10086006
- Address
- 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
US Agent
- Business Name
- LSI International
- Contact Name
- Joe Shia
- Address
- 504E Diamond Ave.
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 5057880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2024-05-17 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2024-05-17 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-10-20 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-11-14 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-11-14 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2022-10-09 |
Proprietary Names
HCG One Step Pregnancy Test Strip OTC
HCG One Step Pregnancy Test Midstream OTC
Vivoo hCG Pregnancy Test
HCG One Step Pregnancy Test Strip Rx
HCG One Step Pregnancy Test Midstream Rx
Pocguide Multi-Drug Test Cup
Pocguide Multi-Drug Test Cup OTC
PocguideTM Multi-Drug Test Panel OTC
PocguideTM Multi-Drug Test Panel
Areta Ovulation Test Strip, ARS-LH
Areta Ovulation Test Kit (AR-S2010)
LH Ovulation Rapid Test
AICHEK LH Ovulation Rapid Test
Areta Ovulation Test Kit (AR-S7020)
easy@Home Ovulation Test, EZW2-S
Areta Ovulation Test Kit (AR-S10030)
Vivoo LH Ovulation Test
Areta Ovulation Test Kit (AR-S3010)
Establishment Types
Manufacture Medical Device