FDA Registration
Active
🇨🇳 China
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
Reg #: 3006113277
·
FEI: 3006113277
·
Expires 2026
Products
11
Proprietary Names
12
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- WENZHOU LONGWAN MEDICAL DEVICE FACTORY
- Registration Number
- 3006113277
- FEI Number
- 3006113277
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District
- City
- Wenzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240165
Owner / Operator
- Firm Name
- Wenzhou Longwan Medical Device Factory
- Operator Number
- 10062272
- Address
- Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District
- City
- Wenzhou
- State
- Zhejiang
- Postal Code
- 325026
- Country
- CN
US Agent
- Business Name
- Medright Tech Inc
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-03-22 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2024-03-22 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2020-12-17 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2023-12-21 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2023-12-21 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2020-12-17 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-12-21 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2020-12-17 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2023-12-21 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2023-12-21 |
| Kit, First Aid, Talking | OVR | Class 1 | General, Plastic Surgery | No | 2023-12-21 |
Proprietary Names
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
Tourniquet
BOTTLE, HOT/COLD WATER
BLOOD PRESSURE CUFF
INFUSOR, PRESSURE, FOR I.V. BAGS
Percussion Hammer
OTOSCOPE
penlight
Stethoscope
SCISSORS, MEDICAL, DISPOSABLE
Goniometer, nonpowered
Kit, first aid, talking
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device