# Assure Tech. (Hangzhou) Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. over-the-counter covid-19 antigen test

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Assure Tech. (Hangzhou) Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Hangzhou Zhejiang, CN |
| New listings | 3 |
| Devices | Over-The-Counter Covid-19 Antigen Test; Sperm, Antigen, Antiserum, Control; Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Product codes | QYT, DFQ, JIN |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology, Immunology, Clinical Chemistry |
| Brand names | Fastep COVID-19 Antigen Pen Test; Fastep COVID-19 Antigen Pen Home Test; Home Sperm Test for Male Fertility; Blood Ketone Test Strips for Keto Diet; Blood Ketone Monitoring System for Keto Die |
| First new listing | 2026-05-26 |
| Latest new listing | 2026-07-27 |
| FDA registration number | 3009585529 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.