Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017396949

FEI Number

3017396949

Entity Name

GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

2nd Floor, No. B3, Huachuang Industry Park, Jinshan Cun, Shiqi , Panyu, Guangzhou, 511400, P.R. China, Room 103, No.11 Shuncheng Street,Nancun,Panyu,511400 Guangzhou, P.R. China, Guangzhou Guangdong 511400, 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 Foam Dressing Dressing, wound, drug LUOFUCON Silicone Foam Dressing LUOFUCON Foam Dressing LOUFUCON Silicone Film Dressing LUOFUCON Silicone Wound Contact Dressing LUOFUCON Silicone Post-Op Dressing LUOFUCON Super absorbent dressing Arthroscope Dressing, wound, drug LUOFUCON Silicone Ag Foam Dressing with Border

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-12-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-12-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-07-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-21

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
3039435289	GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO., LTD.	Dongguan 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

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 3017396949. Last updated year: 2026. Please use registration number 3017396949 when referencing this establishment in official correspondence.