Weihai Hongyu Medical Devices Co., Ltd.
Registered establishment in Weihai, Shandong, China. 3 device types, 1 clearance.
Weihai Hongyu Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Non-Surgical Gown, Needle, Hypodermic, Single Lumen and 1 other device type. Its earliest product listing with the FDA dates from 2010.
3device types registered with the FDA
1510(k) clearance
Registration
| Registered name | WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008381300 |
| FEI number | 3008381300 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 威海鸿宇医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Weihai |
|---|---|
| Province | Shandong |
| Address | No. 86 Shenzhen Road |
| Postal code | 264200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Clean-swaps, Sampling flocked swab | 2020 | 186 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable Blood Collection Needle | 2012 | 71 |
| Non-Surgical Gown | Class 1 | General Gown | 2010 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K103587 | 2011-04-06 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Surgical masks, Protective clothing, Surgical gowns, Isolation gowns, Blood collection tubes |
| Certifications | CE, Medical device registration |
| Export markets | International (EU markets) |
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.