Surearly Smart
Surearly SMART is a self-testing in vitro diagnostic device for home-use that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG,…
Surearly SMART is a self-testing in vitro diagnostic device for home-use that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (4), Guangdong (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Baoding Abiores Chip Co., Ltd. | Baoding | Hebei | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
Showing 12 of 38. All 38 manufacturers in China registered for Test, Luteinizing Hormone (Lh), Over The Counter
Record
| Listed by | Sugentech Inc._Osong Branch |
|---|---|
| FDA product code | NGE |
| Device type | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Premarket notification | Exempt |
| Record published | 2026-05-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature 2 to 30 °C; Special storage condition: Keep away from direct sunlight, moisture and heat |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Surearly SMART | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearblue | SPD Swiss Precision Diagnostics Gmbh | 19 |
| Ferticare | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 9 |
| Wondfo | Wondfo USA Co., Ltd. | 7 |
| One Step® LH Ovulation Rapid Test Dipstick (Urine) | Guangzhou Decheng Biotechnology Co., Ltd. | 6 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| iProvèn | Masena Invest B.V. | 5 |
| Firstview Luteinizing Hormone Rapid Test Strip | Safecare Biotech(Hangzhou)Co., Ltd. | 4 |
| Macro & Micro-Test LH Test | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 4 |
| Egens | Nantong Egens Biology Technic Co., Ltd. | 4 |
| MissLan | Guangzhou Decheng Biotechnology Co., Ltd. | 4 |
| VeriQuick | Fourstar Group | 3 |
| Modern Fertility Ovulation Test | Modern Healthcare Corp. | 3 |
Showing 12 of 69. All products under Test, Luteinizing Hormone (Lh), Over The Counter
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.