FDA Registration
Active
🇨🇳 China
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
Reg #: 3012116434
·
FEI: 3012116434
·
Expires 2026
Products
8
Proprietary Names
35
Establishment Types
3
Classifications
8
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
- Registration Number
- 3012116434
- FEI Number
- 3012116434
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 2 Guanyin Road Economic Development
- City
- Taihu Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211555
Owner / Operator
- Firm Name
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Operator Number
- 10052857
- Address
- No. 2 Guanyin Road, Economic Development Zone, Taihu
- City
- Anqing
- State
- Anhui
- Postal Code
- 246400
- Country
- CN
- Correspondent
- Tiantian Ye
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-10-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-10-18 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-10-18 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2016-10-12 |
| Low Dead Space Piston Syringe | QNQ | Class 2 | General Hospital | No | 2022-05-27 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-10-24 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2016-10-12 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2022-04-12 |
Proprietary Names
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
Blood Collection Needle Holder
21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G
0.3mL, 0.5mL,1mL
LDV(Low Dead Volume) Syringe
Safety Blood Collection Needle (Without Needle Holder)
Needle Gauge: 25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G;
Needle Length: 3/4 ~1 1/2
Needle Gauge: 22G, 23G, 24G, 25G, 26G, 27G
Volume: 05 mL, 0.1 mL, 0.3 mL, 0.5 mL, 1 mL
HWJECT Auto-Disable Syringe
ASPIRATION AND INJECTION NEEDLE
BLUNT FILL NEEDLE W/FILTER or W/O FILTER
25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G
Blood Collection Needle (with/without Needle Holder)
3/4, 1, 1 1/8, 1 1/4,1 2/5, 1 1/2
Needle Gauge: 30G, 29G, 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G, 17G, 16G, 15G
Syringe Volume: 1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, 50 mL, 60 mL, 100 mL
Sterile Hypodermic Syringe with/without Needle; Sterile Hypodermic Needle
Insulin Syringe
Needle Gauge: 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G
Volume: 0.3 mL, 0.5 mL, 1mL
Safety hypodermic needle with syringe/Guardian ShieldTM hypodermic needle with syringe
Safety hypodermic needle/Guardian ShieldTM hypodermic needle
Safety Blood Collection Sets for Single Use
Needle Length: 4mm~12mm
Insulin Pen Needle
Needle Gauge: 28G, 29G, 30G, 31G, 32G, 33G, 34G
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
Safety Blood Collection Needles with/without Needle Holder
3/4~1 1/2
18G,19G,20G,21G,22G,23G,24G,25G
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)