Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 3 device types, 1 product catalogued, 2 clearances.
Hunan Handlike Minimally Invasive Surgery Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Instrument, Ultrasonic Surgical, Laparoscopic Accessories, Gynecologic and 1 other device type. Its earliest product listing with the FDA dates from 2013.
3device types registered with the FDA
1product
2510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010594949 |
| FEI number | 3010594949 |
| DUNS | 544338343 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 湖南瀚德微创医疗科技有限公司 |
|---|---|
| Unified social credit code | 9143010056765737XB |
| Source | NMPA UDI database |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | A4,Lugu Yuyuan,#27,Wenxuan Rd,High-tech Zone |
| Postal code | 410205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Reusable endoscopic surgical instruments, Disposable endoscopic surgical instruments | 2018 | 65 |
| Instrument, Ultrasonic Surgical | Class U | Ultrasonic Surgical System, model HD-CSXT-001 | 2024 | 7 |
| Laparoscopic Accessories, Gynecologic | Class 1 | Laparoscopic accessories, Cholangiography Forceps, Reference code HD1010116, HD1020116, HD1010106, HD1010136, Curved Needle Holder (Single Action), Reference code HD1020431, HD1020401, Straight Needle Holder (Single Action), Reference code HD1020432, HD1020402 | 2013 | 7 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233036 | 2024-06-18 | LFL | Traditional | This company |
| K171825 | 2018-02-13 | GEI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Laparoscopic instruments, Needle holders, Ultrasonic surgical systems, Biopsy forceps, Laparoscopic accessories |
| Certifications | CE, ISO13485, GMP, FDA 510K |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.