Data / Medical devices / China / Weihai Hongyu Medical Devices Co., Ltd.
Weihai Hongyu Medical Devices Co., Ltd.: FDA-registered device maker in Weihai Shandong, China, 1 510(k) clearance
Weihai Hongyu Medical Devices Co., Ltd. is registered with the FDA (registration 3008381300) in Weihai Shandong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008381300
- Address
- No. 19-1 Guotai Road Economy & Technic Development Area, Weihai Shandong, China, 264200
- Owner or operator
- Weihai Hongyu Medical Devices Co., Ltd. (10032291)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 29, 2010
- Registered through
- 2026
- Brand names listed
- Clean-swaps, Disposable Blood Collection Needle, General Gown, Sampling flocked swab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2011 | K103587 | DISPOSABLE BLLOD COLLECTION NEEDLE | FMI | Substantially Equivalent | Weihai Hongyu Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Non-Surgical Gown
Updated April 6, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.