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
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-03-16 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2024-11-25 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2024-11-29 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2025-03-23 |
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