Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038550164

FEI Number

3038550164

Entity Name

BEIJING KREATE MEDICAL CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

C306, West Ring South Road #18, E-town, Beijing 100023, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Kreate Medical Co., Ltd. (Owner Number: 10095208)

Owner / Operator Contact Address

C306, West Ring South Road #18, E-town, Beijing, CN-BJ 100023, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260020

PMA Number

N/A

All Registered Proprietary Names

Redermax Antibacterial Wound Matrix SurCura Antibacterial Wound Matrix Redermo Wound Matrix SurCura Wound Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-02-05
QSZ	Absorbable Synthetic Wound Dressing	Unknown	Class U	N/A	2026-04-19

Official Correspondent

Xiangfei Gao

US Agent Details

SEAN CHEN Email: sean.chen@kreatemed.com Phone: (949) 2795738

Related Public Records

Same Entity

Beijing Kreate 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
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

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 3038550164. Last updated year: 2026. Please use registration number 3038550164 when referencing this establishment in official correspondence.