Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012629741

FEI Number

3012629741

Entity Name

POLYZON SCIENCES Co., LTD

City/State/Country

Shanghai, CN

Establishment Address

604B, #69, 1688 NORTH GUOQUAN ROAD, YANGPU DISTRICT, Shanghai 200433, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

POLYZON SCIENCES Co., Ltd (Owner Number: 10051970)

Owner / Operator Contact Address

ROOM 503, BUILDING 2, 458 GUOXIA ROAD,YANGPU DISTRICT, Shanghai, CN-SH 200433, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-05-31
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-05-31
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-05-25
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-02-25
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-02-06
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-11-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-05-25
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-02-25

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

POLYZON SCIENCES Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012629741. Last updated year: 2026. Please use registration number 3012629741 when referencing this establishment in official correspondence.