FDA Registration
Active
🇨🇳 China
U-PLAY PRODUCTS CORPORATION
Reg #: 3014142845
·
FEI: 3014142845
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- U-PLAY PRODUCTS CORPORATION
- Registration Number
- 3014142845
- FEI Number
- 3014142845
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7 Fumin Road, Wuhu Area of China (Anhui) Pilot Free Trade Zone
- City
- wuhu Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202137
Owner / Operator
- Firm Name
- U-PLAY PRODUCTS CORPORATION
- Operator Number
- 10056213
- Address
- 7 Fumin Road, Wuhu Area of China (Anhui) Pilot Free Trade Zone
- City
- Wuhu
- State
- Anhui
- Postal Code
- 241000
- Country
- CN
- Correspondent
- Wei Zhai
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 |
|---|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2017-11-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-02-23 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-01-07 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-02-23 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-03-26 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2017-11-16 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-05-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-27 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-05-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2020-01-07 |
Proprietary Names
Diaper, Pull-up Diaper, Soft tissue, Soft Facial Tissue; Disposable bath towel; Multi-purpose towel
Coverall
Wet Wipe
Face Mask
Disposable Medical Mask
Under pad
Isolation Mask
Face Mask, Isolation Mask
Cotton pad
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device