Data / Medical devices / China / Hangzhou Aichek Medical Technology Co., Ltd.
Hangzhou Aichek Medical Technology Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 3 510(k) clearances
Hangzhou Aichek Medical Technology Co., Ltd. is registered with the FDA (registration 3025349997) in Hangzhou Zhejiang, China. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025349997
- Address
- 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, Hangzhou Zhejiang, China, 310018
- Owner or operator
- Hangzhou Aichek Medical Technology Co., Ltd. (10086006)
- Roles
- Manufacturer
- First device listed
- October 9, 2022
- Registered through
- 2026
- Brand names listed
- AICHEK LH Ovulation Rapid Test, Areta Ovulation Test Kit (AR-S10030), Areta Ovulation Test Kit (AR-S2010), Areta Ovulation Test Kit (AR-S3010), Areta Ovulation Test Kit (AR-S7020), Areta Ovulation Test Strip, ARS-LH, Easy@Home Pregnancy Test, HCG One Step Pregnancy Test Midstream OTC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Test, Amphetamine, Over The Counter | NFT | 2 | Manufacturer | accessdata.fda.gov |
| Test, Barbiturate, Over The Counter | PTH | 2 | Manufacturer | accessdata.fda.gov |
| Test, Benzodiazepine, Over The Counter | NFV | 2 | Manufacturer | accessdata.fda.gov |
| Test, Cannabinoid, Over The Counter | NFW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | 2 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Test, Methadone, Over The Counter | PTG | 2 | Manufacturer | accessdata.fda.gov |
| Test, Methamphetamine, Over The Counter | NGG | 2 | Manufacturer | accessdata.fda.gov |
| Test, Opiates, Over The Counter | NGL | 2 | Manufacturer | accessdata.fda.gov |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | U | Manufacturer | accessdata.fda.gov |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | 2 | Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2024 | K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | NFT | Substantially Equivalent | Aicheck Biotech, Inc. | accessdata.fda.gov |
| August 14, 2024 | K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | NFT | Substantially Equivalent | Aicheck Biotech, Inc. | accessdata.fda.gov |
| April 12, 2024 | K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | LCX | Substantially Equivalent | Hangzhou Aichek Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Amphetamine, Over The Counter
- All makers of Test, Methamphetamine, Over The Counter
- All makers of Test, Cannabinoid, Over The Counter
- All makers of Test, Methadone, Over The Counter
Updated October 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.