FDA Registration
Active
🇨🇳 China
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
Reg #: 3005202235
·
FEI: 3005202235
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3005202235
- FEI Number
- 3005202235
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NORTH JINHUAN ROAD
- City
- SHANTOU Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K113587
Owner / Operator
- Firm Name
- Shantou Wealy Medical Instrument Co., Ltd
- Operator Number
- 9074040
- Address
- North Jinhuan Road
- City
- Shantou
- State
- Guangdong
- Postal Code
- 515064
- Country
- CN
- Correspondent
- Clare - Yang
US Agent
- Business Name
- Kavalan Consulting Inc
- Contact Name
- Ruth Wu
- Address
- 1000 Valley Forge Cir
- City
- King of Prussia
- State
- PA
- ZIP
- 19406
- Country
- US
- [email protected]
- Phone
- 610 3102793
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2005-09-12 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2012-03-08 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-12-05 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-12-05 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2021-09-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-12-31 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2007-12-28 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2005-08-03 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2007-12-28 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2023-09-14 |
Proprietary Names
Wealy Syringe
Wealy Antistick Syringe
Disposable Automatically Retractable Safety Syringes (with detachable needle)
Disposable Automatically Retractable Insulin Safety Syringe
ENFit Reusable Enteral Syringe
Sharps Safety Station Needle Counter Box
Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, 10ml)
epidural tray
ENFit Disposable Enteral Syringe
Wealy Gauze
Reusable oral syringes
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)