Weony (Shenzhen) Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 3 products catalogued, 2 clearances.
Weony (Shenzhen) Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, Measurement, Blood-Pressure, Non-Invasive. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
1device type
3products catalogued under its own name
2510(k) clearances
Registration
| Registered name | WEONY (SHENZHEN) TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021247088 |
| FEI number | 3021247088 |
| DUNS | 419815000 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 401, the 6th building, Changfeng Industrial Zone, Dongkeng Community, Fenghuang Street |
| Postal code | 518132 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | WBP203, WBP202, WBP206, WBP204, WBP205, WBP108 and 16 more | 2021 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| weony | DXN | 4 |
| StrongHealth | DXN | 1 |
| Medmac | DXN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231542 | 2023-09-07 | DXN | Traditional | This company |
| K210671 | 2021-08-13 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Digital blood pressure monitors, Digital thermometers, Infrared thermometers, Non-contact forehead thermometers, Compressor nebulizers |
| Export markets | Worldwide |
| 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.
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