Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014666579

FEI Number

3014666579

Entity Name

SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.

City/State/Country

Zaozhuang Shandong, CN

Establishment Address

Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Province, China, Zaozhuang Shandong 277117, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Kangli Medical Equipment Technology Co., Ltd. (Owner Number: 10058066)

Owner / Operator Contact Address

Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Province, China, Zaozhuang, CN-SD 277117, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cotton Ball Sterile Draw Sheets Disposable medical surgical gown Hydrofiber Medical Calcium Alginate Dressing Colostomy Bag Wrapping Cloth Colostomy bags Adhesive Strips Adhesive Mouldable Ring Barrier Cream Sterile Gauze Bandages Sterile Self-adhesive Wound Dressings Swelling Chitosan Transparent dressing PU Foam Dressing Medical Hydrocolloid Dressing Keto-silicone Dressing Bed Sheets Disposable Transfer Sheets Gauze Pad Gauze Piece Plastic Tweezers Medical Tapes Shoe cover Breast Drape General Operation Drape Cesarean section Drape Knee Drape Coronary Angiography Drape Laparotomy Drape Head Drape Sterile Surgical Caps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-07-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-07-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-06-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-07-04
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2018-09-25
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-07-04
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2020-09-22
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-09-25
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-07-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-07-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-07-04
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2018-09-25
FNW	Pad, Kelly	General, Plastic Surgery	Class 2	878.4370	2018-09-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-07-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-07-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-09-25
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-06-21
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-12-17
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2018-07-03

Official Correspondent

Zhuang Liu

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shandong Kangli Medical Equipment Technology 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014666579. Last updated year: 2026. Please use registration number 3014666579 when referencing this establishment in official correspondence.