Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 17 device types.
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Retractor and 15 other device types. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007675948 |
| FEI number | 3007675948 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 杭州桐庐时空候医疗器械有限公司 |
|---|---|
| Unified social credit code | 91330122785331888Q |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No. 100 Sangyuan Rd |
| Postal code | 311501 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Bulbs, Miscellaneous, For Endoscope | Class 1 | 2025 | 6 | |
| Applier, Surgical, Clip | Class 1 | 2014 | 9 | |
| Clamp | Class 1 | 2014 | 24 | |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | 2020 | 65 | |
| Forceps, Biopsy, Non-Electric | Class 1 | SurgyCut Grasping Forceps, SugyCut Biopsy Forceps | 2024 | 44 |
| Forceps, General & Plastic Surgery | Class 1 | 2014 | 27 | |
| Guide, Needle, Surgical | Class 1 | 2014 | 32 | |
| Hemostat, Surgical | Class 1 | 2014 | 4 | |
| Hook, Surgical, General & Plastic Surgery | Class 1 | 2014 | 19 | |
| Instrument, Manual, Surgical, General Use | Class 1 | 2014 | 110 | |
| Irrigator, Sinus | Class 1 | 2014 | 27 | |
| Knife, Surgical | Class 1 | 2014 | 8 | |
| Needle, Aspiration And Injection, Disposable | Class 1 | 2020 | 37 | |
| Pliers, Surgical | Class 1 | 2014 | 11 | |
| Retractor | Class 1 | 2014 | 34 | |
| Scissors, General, Surgical | Class 1 | 2014 | 83 | |
| Stripper, Vein, Disposable | Class 1 | 2014 | 3 |
Clearances
No clearance names Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K911316 | 1991-04-29 | GEI | Traditional | Northgate Technologies Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Main products | Rigid endoscopes, Laparoscopic instruments, Disposable surgical instruments, Gynecological instruments, Endoscopic equipment |
| Certifications | CE, FDA, ISO9001:2000, ISO13458:1996 |
| Export markets | 70+ countries including US, Germany, UK, Japan, Italy, India |
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.