FDA Registration Active 🇨🇳 China

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Reg #: 3034630389 · FEI: 3034630389 · Expires 2026
Products
4
Proprietary Names
20
Establishment Types
1
Classifications
4

Registration Details

Registration Name
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Registration Number
3034630389
FEI Number
3034630389
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Room 5002, 5003, 5004, A01 Building, No.74 Chuangyu Road, Ningxi Street, Zengcheng District
City
Guangzhou Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K253951

Owner / Operator

Firm Name
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Operator Number
10092017
Address
Room 208, Building C, No. 3, Juquan Road, Huangpu District
City
Guangzhou
State
Guangdong
Postal Code
510000
Country
CN
Correspondent
Zhengzhou Li

US Agent

Business Name
Regrek LLC
Contact Name
Leeyeo Kee
Address
19 Holly Cove Ln
City
Dover
State
DE
ZIP
19901
Country
US
Phone
302 6089028

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX
Device, Cystometric, Hydraulic FEN
Uroflowmeter EXY
Lithotriptor, Electro-Hydraulic FFK

Proprietary Names

Holmium Laser Therapeutic Apparatus (HZ-A) Holmium Laser Therapeutic Apparatus (HZ-B) Holmium Laser Therapeutic Apparatus (HZ-E) Holmium Laser Therapeutic Apparatus (HZ-40) Urodynamic Systems Holmium Laser System (Potent HP150) Holmium Laser System (Potent HP140) Holmium Laser System (Potent HP120) Holmium Laser System (Potent HP100) Holmium Laser System (Potent HP90) Uroflowmeters Systems PT-OF-A-S PT-OF-C-S PT-OF-B-S PT-OF-D-S PT-OF-E-S PT-OF-F-S Electrohydraulic Lithotriptor (TCS-B3-II) Thulium Fiber Laser System (TFL-A) Thulium Fiber Laser System (TFL-B)

Establishment Types

Manufacture Medical Device