Manufacturer and brand owner in Shaoxing, Zhejiang, China. 14 device types, 17 products catalogued, 2 clearances.
Zhende Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Gown, Surgical, Mask, Surgical and 12 other device types. 17 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2002.
Registration
FDA registration record for Zhende Medical Co., Ltd. | Registered name | ZHENDE MEDICAL CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003348807 |
| FEI number | 3003348807 |
| DUNS | 654591569 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
Address of Zhende Medical Co., Ltd. | City | Shaoxing |
| Province | Zhejiang |
| Address | GAOBU TOWN |
| Postal code | 312035 |
| Country | China |
Clearances
2 clearances name Zhende Medical Co., Ltd. as applicant. 1 is 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.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Zhende Medical Co., Ltd. | Founded | 1994 |
| Main products | medical dressings, surgical room infection control products, chronic wound care products, pressure therapy products, personal protective equipment |
| Certifications | Medical Device Production License, Class I Medical Device Production Filing, Internet Drug Information Service Certificate |
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.