Data / Medical devices / China / Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.: FDA-registered device maker in Taihu Anhui, China, 12 510(k) clearances
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. is registered with the FDA (registration 3012116434) in Taihu Anhui, China. It lists 8 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 19, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012116434
- Address
- No. 2 Guanyin Road Economic Development, Taihu Anhui, China, 246400
- Owner or operator
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (10052857)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 12, 2016
- Registered through
- 2026
- Brand names listed
- 0.3mL, 0.5mL,1mL, 18G,19G,20G,21G,22G,23G,24G,25G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G, 3/4, 1, 1 1/8, 1 1/4,1 2/5, 1 1/2, 3/4~1 1/2, ASPIRATION AND INJECTION NEEDLE, BLUNT FILL NEEDLE W/FILTER or W/O FILTER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Dead Space Piston Syringe | QNQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 19, 2024 | K234024 | HWJECT Auto-disable syringe | FMF | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| November 30, 2023 | K230061 | Insulin Syringe | FMF | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| September 20, 2023 | K230043 | Insulin Pen Needle | FMI | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| March 24, 2023 | K223323 | Blood Collection Needle (with/without Needle Holder) | JKA | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| November 4, 2022 | K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | FMI | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| October 21, 2022 | K222141 | Safety Blood Collection Needle (Without Needle Holder) | JKA | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| August 10, 2022 | K220900 | Safety Blood Collection Needles with/without Needle Holder | JKA | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| May 25, 2022 | K220083 | LDV((Low Dead Volume )Syringe | QNQ | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| April 12, 2022 | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | FMI | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| October 18, 2021 | K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | MEG | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| February 19, 2021 | K202188 | Safety Blood Collection Sets for Single Use | JKA | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
| October 4, 2019 | K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | MEG | Substantially Equivalent | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Antistick
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, Administration, Intravascular
- All makers of Needle, Aspiration And Injection, Disposable
Updated March 19, 2024. 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.