Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 13 device types, 5 products catalogued, 1 clearance.
Hangzhou Aichek Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Test, Opiates, Over The Counter, Test, Methadone, Over The Counter and 11 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3025349997 |
| FEI number | 3025349997 |
| DUNS | 548416054 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州艾策医疗技术有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District |
| Postal code | 310018 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Midstream Rx, Vivoo hCG Pregnancy Test, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Strip Rx | 2024 | 30 |
| Test, Amphetamine, Over The Counter | Class 2 | Pocguide Multi-Drug Test Cup OTC, Pocguide Multi-Drug Test Cup, PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | AICHEK LH Ovulation Rapid Test, Areta Ovulation Test Kit (AR-S2010), Areta Ovulation Test Kit (AR-S10030), Vivoo LH Ovulation Test, easy@Home Ovulation Test, EZW2-S, LH Ovulation Rapid Test and 3 more | 2022 | 38 |
| Test, Methadone, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Test, Opiates, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 12 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | PocguideTM Multi-Drug Test Panel OTC, PocguideTM Multi-Drug Test Panel | 2024 | 16 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Midstream Rx, Vivoo hCG Pregnancy Test, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Strip Rx | 2024 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Pocguide Multi-Drug Test Panel | NFT | 4 |
| Pocguide Multi-Drug Test Cup | NFT | 4 |
| Pocguide Multi-Drug Test Panel OTC | NFT | 1 |
| SnapCheckDx Rapid Urine THC Test | NFW | 1 |
| Pocguide Multi-Drug Test Cup OTC | NFT | 1 |
Clearances
1 clearance names Hangzhou Aichek Medical Technology Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233624 | 2024-04-12 | LCX | Traditional | This company |
| K242498 | 2024-10-01 | NFT | Traditional | Aicheck Biotech, Inc. |
| K242077 | 2024-08-14 | NFT | Traditional | Aicheck Biotech, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | POCT rapid tests, Chemiluminescence immunoassay, Biochemistry diagnostics, Antigen test kits, Fluorescence immunoassay |
| Certifications | ISO13485:2016, MDSAP, CE |
| Export markets | Global |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.