Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007124979

FEI Number

3007124979

Entity Name

Roosin Medical Co., Ltd.

City/State/Country

Taizhou Jiangsu, CN

Establishment Address

No.8 Yuandong Road, Kouan Town, Gaogang, Taizhou Jiangsu 225321, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Roosin Medical Co., Ltd. (Owner Number: 10026552)

Owner / Operator Contact Address

No.8 Yuandong Road, Kouan Town, Gaogang, Taizhou, CN-JS 225321, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181478

PMA Number

N/A

All Registered Proprietary Names

Roosin Collagen Dressing HOLDER, URETERAL CATHETER CALCIUM ALGINATE WOUND DRESSING HYDROCOLLOID DRESSING ISLAND DRESSING GELLING FIBER DRESSING Polyver Silver Alginate Dressing (Prescription and OTC) PRP Vacuum Tube-PRF Hydrocolloid Dressing Roosin Xeroform Petrolatum Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-06-04
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-11-13
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2008-07-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-11-18
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2025-02-26
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2013-10-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Roosin Medical 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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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

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3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007124979. Last updated year: 2026. Please use registration number 3007124979 when referencing this establishment in official correspondence.