FDA Registration
Active
🇨🇳 China
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD
Reg #: 3016710298
·
FEI: 3016710298
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3016710298
- FEI Number
- 3016710298
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 9 Jinfeng Road, Suzhou Science & Technology Town
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203347
Owner / Operator
- Firm Name
- SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD
- Operator Number
- 10091669
- Address
- No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou Jiangsu, CN 215163
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215163
- Country
- CN
- Correspondent
- Yiliang Zhang
US Agent
- Business Name
- Yuwell MedTech USA LLC
- Contact Name
- Fang(Fawn) Zhang
- Address
- 7545 Irvine Center Dr Suite 200 Irvine Ca 92618 Usa
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 206 6391311
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2024-10-23 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2025-09-25 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2024-10-22 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2024-10-23 |
Proprietary Names
YUWELL Standard conical connector
Yuwell Sleep Apnea Breathing Therapy Mask
Headgear
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)