Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Taihu Anhui, CN
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. appears in FDA device records in Taihu Anhui, CN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. between 2019 and 2024. The busiest year on record is 2022, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234024 | HWJECT Auto-disable syringe | FMF | Substantially Equivalent | |
| K230061 | Insulin Syringe | FMF | Substantially Equivalent | |
| K230043 | Insulin Pen Needle | FMI | Substantially Equivalent | |
| K223323 | Blood Collection Needle (with/without Needle Holder) | JKA | Substantially Equivalent | |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | FMI | Substantially Equivalent | |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | JKA | Substantially Equivalent | |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | JKA | Substantially Equivalent | |
| K220083 | LDV((Low Dead Volume )Syringe | QNQ | Substantially Equivalent | |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | FMI | Substantially Equivalent | |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | MEG | Substantially Equivalent | |
| K202188 | Safety Blood Collection Sets for Single Use | JKA | Substantially Equivalent | |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | MEG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012116434 | 3012116434 | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. | No. 2 Guanyin Road Economic Development, Taihu Anhui 246400 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QNQLow Dead Space Piston Syringe
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- FPASet, Administration, Intravascular
- MEGSyringe, Antistick
- FMFSyringe, Piston
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain