FDA Registration
Active
🇨🇳 China
HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTD
Reg #: 3007675948
·
FEI: 3007675948
·
Expires 2026
Products
17
Proprietary Names
1
Establishment Types
3
Classifications
17
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Registration Details
- Registration Name
- HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTD
- Registration Number
- 3007675948
- FEI Number
- 3007675948
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 100 Sangyuan Rd, Hangzhou Tonglu EconomicDevelopment Zone
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K911316
Owner / Operator
- Firm Name
- Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd.
- Operator Number
- 10046214
- Address
- No. 100, Sangyuan Road, Tonglu Economic Development Zone
- City
- Tonglu
- State
- Zhejiang
- Postal Code
- 311501
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-07-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2025-01-02 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2014-02-18 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Stripper, Vein, Disposable | GAJ | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2014-02-18 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-08-27 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2020-07-14 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2014-02-18 |
Proprietary Names
SurgyCut Grasping Forceps, SugyCut Biopsy Forceps
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)