FDA Registration
Active
🇨🇳 China
Jiangsu Newvalue Medical Products Co., Ltd.
Reg #: 3027517726
·
FEI: 3027517726
·
Expires 2026
Products
12
Proprietary Names
21
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- Jiangsu Newvalue Medical Products Co., Ltd.
- Registration Number
- 3027517726
- FEI Number
- 3027517726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.22 Zelan Road, China Medical City
- City
- Taizhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213413
Owner / Operator
- Firm Name
- Jiangsu Newvalue Medical Products Co., Ltd.
- Operator Number
- 10048334
- Address
- No.22 Zelan Road, China Medical City
- City
- Taizhou
- State
- Jiangsu
- Postal Code
- 225300
- Country
- CN
- Correspondent
- Yan Shi
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 |
|---|---|---|---|---|---|
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2024-10-27 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2014-12-30 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2026-01-19 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2014-12-30 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2018-04-25 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2024-04-22 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2024-06-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-12-30 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2021-04-22 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2014-12-30 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-02-18 |
| 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 | 2020-03-31 |
Proprietary Names
Skin Barrier Strips
Skin Barrier Ring
Skin Barrier Arc
Pack, Hot or Cold, disposable (Hydrogel patch)
Hydrogel Dressing
Dressing, wound, hydrophilic (Alginate dressing)
Intravascular Catheter Securement
Hemostatic Dressing
silicone scar sheets
Silicone Scar Gel
Self-Adherent Scar Care Dressing
Skin Closure Strips
SURECELL Gelling Fiber Wound Dressing
Dressing, wound, occlusive (Hydrocolloid dressing, foam dressing, silicone adhesive dressing)
ACNE PIMPLE PATCHES
Silicone Bordered Gauze
Silicone Clear Dressing,Silicone Mesh,Wound Contact Layer,Silicone Dressing
Hydrocolloid Roll
Water Tight Bandages
Disposable Surgical Face Mask
Medical Face Mask
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