FDA Registration
Active
🇨🇳 China
Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Reg #: 3010594949
·
FEI: 3010594949
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Registration Number
- 3010594949
- FEI Number
- 3010594949
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A4,Lugu Yuyuan,#27,Wenxuan Rd,High-tech Zone
- City
- Changsha Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233036
Owner / Operator
- Firm Name
- Hunan Handlike Minimally Invasive Surgery Co.,Ltd.
- Operator Number
- 10045334
- Address
- A4,Lugu Yuyuan,#27,Wenxuan Rd,High-tech Zone
- City
- Changsha
- State
- Hunan
- Postal Code
- 410205
- Country
- CN
- Correspondent
- Jiajie Yan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2024-06-20 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2013-11-06 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-04-16 |
Proprietary Names
Ultrasonic Surgical System, model HD-CSXT-001
Laparoscopic accessories
Curved Needle Holder (Single Action), Reference code HD1020431, HD1020401
Cholangiography Forceps, Reference code HD1010116, HD1020116, HD1010106, HD1010136
Straight Needle Holder (Single Action), Reference code HD1020432, HD1020402
Disposable endoscopic surgical instruments
Reusable endoscopic surgical instruments
Establishment Types
Manufacture Medical Device