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

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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
Phone
931 6254938

Products

Device Name Product Code
Syringe, Piston FMF
Needle, Hypodermic, Single Lumen FMI
Syringe, Antistick MEG
System, Blood Collection, Vacuum-Assisted, Manual KST
Low Dead Space Piston Syringe QNQ
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Needle, Aspiration And Injection, Disposable GAA
Set, Administration, Intravascular FPA

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)