FDA Registration
Active
🇨🇳 China
POLYZON SCIENCES Co., LTD
Reg #: 3012629741
·
FEI: 3012629741
·
Expires 2026
Products
12
Proprietary Names
34
Establishment Types
5
Classifications
12
Registration Details
- Registration Name
- POLYZON SCIENCES Co., LTD
- Registration Number
- 3012629741
- FEI Number
- 3012629741
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 604B, #69, 1688 NORTH GUOQUAN ROAD, YANGPU DISTRICT
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K143335
Owner / Operator
- Firm Name
- POLYZON SCIENCES Co., Ltd
- Operator Number
- 10051970
- Address
- ROOM 503, BUILDING 2, 458 GUOXIA ROAD,YANGPU DISTRICT
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200433
- Country
- CN
- Correspondent
- Charles Shen
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2021-05-31 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-05-31 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2016-05-25 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2024-02-25 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-02-06 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-02 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2016-05-25 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2024-02-25 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-16 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2016-05-25 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2021-05-31 |
Proprietary Names
Silver Alginate Dressing
NON-WOVENTAPE
Foam Dressing
Honey Gauze Dressing
Petrolatum dressing
Paraffin Gauze
Waterproof Bordered Foam Dressing
Super Absorbent Dressing
Pediatric Gauze
Oil Emulsion dressing
WATERPROOF COMPOSITE DRESSING
Silicone Foam Dressing
Transparent dressing
Xeroform Petrolatum Gauze Dressing
Sterile honey gel wound dressing
DEVICE ,INTRAVASCULAR CATHETER SECUREMENT
Kit
Isolation Mask
NON-SURGICAL ISOLATION GOWN
Polyver Silver Alginate Dressing (Prescription and OTC)
Calcium Alginate Wound Dressings
ISLAND DRESSING
BORDERED GAUZE DRESSING
Honey Calcium Alginate Dressing
COVER DRESSING
HYDROCOLLOID DRESSING
CALCIUM ALGINATE WOUND DRESSING
HOLDER ,URETERAL CATHETER
ISOLATION MASK
Sterile Burn Dressing
Amorphous Hydrogel Dressing
Hydrogel Gauze
Hydrogel Medical Dressing
Silicone Dressing scarcinpad
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)