Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039435289

FEI Number

3039435289

Entity Name

GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 103, Building 2, No. 17 Jinchuan Second Road, Xiegang, Dongguan Guangdong 523596, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guang Zhou MedClear Medical Device Service Co.,Ltd. (Owner Number: 10063736)

Owner / Operator Contact Address

2nd Floor, No. B3, Huachuang Industry Park, Jinshan Cun, Shiqi , Panyu, Guangzhou, 511400, P.R. China, Guangzhou, CN-GD 511400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LUOFUCON Silicone Ag+ Antibacterial Foam Dressing LUOFUCON Silicone Ag+ Foam Dressing LUOFUCON Silicone Ag Foam Dressing Dressing, wound, drug LUOFUCON Silicone Post-Op Dressing LUOFUCON Super absorbent dressing LUOFUCON Silicone Foam Dressing LUOFUCON Foam Dressing LOUFUCON Silicone Film Dressing LUOFUCON Silicone Wound Contact Dressing Dressing, wound, drug LUOFUCON Silicone Ag Foam Dressing with Border LUOFUCON Composite Dressing Suction Catheters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-08-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-12-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-12-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-21
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2025-08-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-03-02
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2025-07-08

Official Correspondent

kevin huang

US Agent Details

Zheng Xu Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Guang Zhou MedClear Medical Device Service Co.,Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017396949	GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO.,LTD.	Guangzhou Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
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 3039435289. Last updated year: 2026. Please use registration number 3039435289 when referencing this establishment in official correspondence.