FDA Registration
Active
🇨🇳 China
HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD
Reg #: 3014542717
·
FEI: 3014542717
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD
- Registration Number
- 3014542717
- FEI Number
- 3014542717
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MINBING ROAD, EAST SHUANGGOU TOWN, HONGZE DISTRICT
- City
- HUAIAN Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K110276
Owner / Operator
- Firm Name
- HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD
- Operator Number
- 10058861
- Address
- MINBING ROAD, EAST SHUANGGOU TOWN, HONGZE DISTRICT
- City
- HUAIAN
- State
- Jiangsu
- Postal Code
- 223121
- Country
- CN
- Correspondent
- Jun Meng
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 |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2018-11-04 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2018-11-04 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-11-04 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2020-02-23 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-11-04 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2019-11-25 |
Proprietary Names
Sleeve, Limb, Compressible Garment
Ice Bucket; Cold Therapy System
Hot&Cold/Therapy Pad, Hot&Cold/Water Therapy Wrap
Hot&Cold / Therapy Pad , Hot&Cold / Water Therapy Wrap, Cold Therapy System
Hot&Cold/Therapy Pad, Hot&Cold/Water Therapy Wrap, Cold Therapy System
Anti-Bedsore Mattress
Establishment Types
Manufacture Medical Device