FDA Registration
Active
🇨🇳 China
TONGLU WANHE MEDICAL INSTRUMENT CO., LTD.
Reg #: 3010611926
·
FEI: 3010611926
·
Expires 2026
Products
24
Proprietary Names
19
Establishment Types
2
Classifications
24
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Registration Details
- Registration Name
- TONGLU WANHE MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3010611926
- FEI Number
- 3010611926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 20, Fuchun Zhichuang Park, No.516, Majia Road, Tonglu
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Tonglu Wanhe Medical Instrument Co., Ltd.
- Operator Number
- 10045600
- Address
- Building 20, Fuchun Zhichuang Park, No.516, Majia Road, Tonglu
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311504
- Country
- CN
- Correspondent
- Zengjun Shentu
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 |
|---|---|---|---|---|---|
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2015-12-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-12-06 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2017-12-27 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2015-12-30 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-12-06 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-12-06 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2013-12-06 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2017-12-27 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2013-12-06 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2013-12-06 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2015-12-30 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2015-12-30 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2013-12-06 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-12-06 |
Proprietary Names
Clip remover
(Thoracotomy instruments)
Clamp
Elevator
Dissecting forceps, Grasping forceps, Suction irrigation tube, Endo bag, Veress needle, cannula
Chisel
(Sinuscopy instruments)
Trocar
Suction irrigation tube, Knot pusher, Rod, Knife, Spatula, Probe, loop, adaptor, Reducer
guide bar, hook, Vaginal plate, sheath, obturator
Uterine elevator, dissector, flexible forceps, Uterine manipulator, Cevical dilator
Closure forceps
Laryngoscopy instruments
hook
Clip applier
Punch forceps
STAPLER, SURGICAL
Cutter, burrs, blade
Aspiration needle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device