Jiangsu Newvalue Medical Products Co., Ltd.
Manufacturer and brand owner in Taizhou, Jiangsu, China. 12 device types, 14 products catalogued, 2 clearances.
Jiangsu Newvalue Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Protector, Ostomy and 10 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
12device types registered with the FDA
14products catalogued under its own name
2510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3027517726 |
| FEI number | 3027517726 |
| DUNS | 544401775 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏诺瓦立医疗用品有限公司 |
|---|---|
| Unified social credit code | 91321291078209517R |
| Source | NMPA UDI database |
Location
| City | Taizhou |
|---|---|
| Province | Jiangsu |
| Address | No.22 Zelan Road, China Medical City |
| Postal code | 225300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Intravascular Catheter Securement | Class 1 | Intravascular Catheter Securement | 2018 | 33 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Hydrogel Dressing | 2026 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Dressing, wound, hydrophilic (Alginate dressing) | 2014 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Dressing, wound, occlusive (Hydrocolloid dressing, foam dressing, silicone adhesive dressing), Silicone Bordered Gauze, Water Tight Bandages, Silicone Clear Dressing,Silicone Mesh,Wound Contact Layer,Silicone Dressing, Acne Pimple Patches, Hydrocolloid Roll | 2014 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Gel, Self-Adherent Scar Care Dressing, silicone scar sheets | 2024 | 85 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Medical Face Mask | 2020 | 182 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Class U | Hemostatic Dressing | 2024 | 10 |
| Mask, Surgical | Class 2 | Disposable Surgical Face Mask | 2021 | 125 |
| Pack, Hot Or Cold, Disposable | Class 1 | Pack, Hot or Cold, disposable (Hydrogel patch) | 2014 | 176 |
| Protector, Ostomy | Class 1 | Skin Barrier Arc, Skin Barrier Ring, Skin Barrier Strips | 2024 | 33 |
| Tape And Bandage, Adhesive | Class 1 | Skin Closure Strips, Transparent film dressing | 2014 | 353 |
| Wound Dressing With Animal-Derived Material(S) | Class U | SURECELL Gelling Fiber Wound Dressing | 2021 | 12 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Ourmed Foam Dressing | NAD | 10 |
| Ourmed Hydrocolloid Dressing | NAD | 8 |
| Disposable Surgical Face Mask | FXX | 3 |
| Ourmed Transparent Dressing | KGX | 3 |
| Hydrocolloid Dressing | NAD | 2 |
| PreviClear Border Sacrum Transparent Gel Dressing | NAE | 2 |
| kegel Hydrocolloid Dressing | NAD | 1 |
| kegel Hydrogel Dressing | NAE | 1 |
| Dr Perfect Hydrocolloid Dressing | NAD | 1 |
| kegel Silicone Scar Sheets | MDA | 1 |
| Acne Pimple Patches | NAD | 1 |
| Dr Perfect Silicone Scar Sheets | MDA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213413 | 2023-09-01 | QSY | Traditional | This company |
| K202491 | 2021-01-06 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Wound dressing, Hemostasis products, Tissue anti-adhesion products, Trauma care |
| Certifications | High-tech enterprise (2024) |
| Export markets | Multiple countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.