Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015937050

FEI Number

3015937050

Entity Name

SHANDONG SUCCARE MEDICAL CO., LTD.

City/State/Country

Zibo City Shandong, CN

Establishment Address

5th Building, Zhongbaohang Zibo Technology & Innovation Park, No. 15 Zihe Avenue, Nanding Town, Zibo Economic Development District, Zibo City Shandong 255051, CN

Establishment Type(s)

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

Owner / Operator

Shandong Succare Medical Co., Ltd. (Owner Number: 10090039)

Owner / Operator Contact Address

5th Building, Zhongbaohang Zibo Technology & Innovation Park, No. 15 Zihe Avenue, Nanding Town, Zibo Economic Development District, Zibo City, CN-SD 255051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Catheter Fixing Dressings Elastic Bandages Alginate Dressings Wound Dressings Dressing Change Kits Catheter Fixing Dressings Hydrocolloid Dressings Transparent Dressings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-02-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-02-06
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-02-06
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2024-02-06
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-02-06
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-02-06

Official Correspondent

Qianqian Wang

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Shandong Succare 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3030433705	TMR PLASTICS	Bydgoszcz Pomorskie, PL
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3011642792	Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, MX
3005023997	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	SHANGHAI, CN
3003152976	BECTON DICKINSON, S.A.	SAN AGUSTIN DE GUADALIX Madrid (Province), ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015937050. Last updated year: 2026. Please use registration number 3015937050 when referencing this establishment in official correspondence.