Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Manufacturer and brand owner in Taihu, Anhui, China. 8 device types, 15 products catalogued, 12 clearances.
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 6 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
8device types registered with the FDA
15products catalogued under its own name
12510(k) clearances
Registration
| Registered name | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012116434 |
| FEI number | 3012116434 |
| DUNS | 543007373 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 安徽宏宇五洲医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 9134082557301408X9 |
| Source | NMPA UDI database |
Location
| City | Taihu |
|---|---|
| Province | Anhui |
| Address | No. 2 Guanyin Road Economic Development |
| Postal code | 246400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Low Dead Space Piston Syringe | Class 2 | LDV(Low Dead Volume) Syringe, 0.3mL, 0.5mL,1mL, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G | 2022 | 5 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Aspiration AND Injection Needle, BLUNT FILL NEEDLE W/FILTER or W/O FILTER | 2016 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder), Needle gauge and length: 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G; 1/2’’~1 1/8’’’, Needle Gauge: 22G, 23G, 24G, 25G, 26G, 27G, HWJECT Auto-Disable Syringe, Volume: 05 mL, 0.1 mL, 0.3 mL, 0.5 mL, 1 mL and 17 more | 2019 | 71 |
| Set, Administration, Intravascular | Class 2 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder), Needle gauge and length: 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G; 1/2’’~1 1/8’’’ | 2022 | 49 |
| Syringe, Antistick | Class 2 | Safety hypodermic needle with syringe/Guardian ShieldTM hypodermic needle with syringe, Safety hypodermic needle/Guardian ShieldTM hypodermic needle, Syringe with Safety Needle, 1,2,3,5,10,20,30,50,60,100 ml, Safety Needle, 18,19,20,21,22,23,24,25,26,27,28,29,30G | 2019 | 39 |
| Syringe, Piston | Class 2 | Volume: 0.3 mL, 0.5 mL, 1mL, Insulin Syringe, Needle Gauge: 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, Needle Gauge: 22G, 23G, 24G, 25G, 26G, 27G, HWJECT Auto-Disable Syringe, Volume: 05 mL, 0.1 mL, 0.3 mL, 0.5 mL, 1 mL and 7 more | 2019 | 60 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Blood Collection Needle Holder | 2016 | 31 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Safety Blood Collection Sets for Single Use, Safety Blood Collection Needles with/without Needle Holder, 3/4”~1 1/2”, 18G,19G,20G,21G,22G,23G,24G,25G, Blood Collection Needle (with/without Needle Holder), 25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G and 4 more | 2021 | 23 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| SOL-Guard Safety Needle | FMI | 29 |
| Syringe with safety needle | MEG | 20 |
| Insulin PEN Needle | FMI | 17 |
| Syringe with needle | MEG | 16 |
| Safety Needle | FMI | 9 |
| Blood Collection Needle with Needle Holder | JKA | 8 |
| Blood Collection Needle without Needle Holder | JKA | 8 |
| Safety Blood Collection Needle (Without Needle Holder) | JKA | 7 |
| Syringe without needle | MEG | 4 |
| Bludraw | JKA | 4 |
| LDV (Low Dead Volume) Syringe | QNQ | 3 |
| Multi-Sample Blood Collection Set | JKA | 3 |
| Hwject Auto-Disable Syringe | FMF | 3 |
| One+Step Insulin PEN Needle | FMI | 1 |
| Safety Blood Collection Needle (Without Needle Holder) | FMI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K234024 | 2024-03-19 | FMF | Traditional | This company |
| K230061 | 2023-11-30 | FMF | Traditional | This company |
| K230043 | 2023-09-20 | FMI | Traditional | This company |
| K223323 | 2023-03-24 | JKA | Traditional | This company |
| K222124 | 2022-11-04 | FMI | Traditional | This company |
| K222141 | 2022-10-21 | JKA | Traditional | This company |
| K220900 | 2022-08-10 | JKA | Traditional | This company |
| K220083 | 2022-05-25 | QNQ | Traditional | This company |
| K214075 | 2022-04-12 | FMI | Traditional | This company |
| K211555 | 2021-10-18 | MEG | Traditional | This company |
| K202188 | 2021-02-19 | JKA | Traditional | This company |
| K190183 | 2019-10-04 | MEG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Factory area | Class 100,000 cleanroom |
| Main products | Safety product series, Injection series, Intravenous infusion series, Diabetes care series, Infusion and puncture products |
| Certifications | 80 product registrations, patent authorizations |
| Export markets | multiple countries |
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.