Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026263452

FEI Number

3026263452

Entity Name

GAUKE INTERNATIONAL TRADING CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

ROOM 201-1, BUILDING 8, NO.10 FENGSHUO ROAD, QIAOKOU DISTRICT, Wuhan Hubei 430035, CN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GAUKE INTERNATIONAL TRADING CO., LTD. (Owner Number: 10092137)

Owner / Operator Contact Address

ROOM 201-1, BUILDING 8, NO.10 FENGSHUO ROAD, QIAOKOU DISTRICT, Wuhan, CN-HB 430035, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forceps/Tweezers Burn Dressing Bum Gel Bum Relieve Pads Alcohol Prep Pad Povidone Iodine Prep Pads Triangular Bandage Sterile Adhesive Bandage Adhesive Tape Roller Bandage First ftjd Dressing Bandages Transparent Wound Dressing Cheat Seal Wound Dressing Scissors Gauze Sponge First Aid Blanket CPR Mask Gauke Brand Splint Roll Alcohol Pad Triangular bandages Stethoscope Cotton Roll Zig-Zag Cotton Roll Cotton Ball Cotton Cotton Tips, Cotton Swabs Heat Pack Cold Compress Pack Face Mask Finger Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-12-08
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-12-08
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-12-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-12-08
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2024-12-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-12-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-12-08
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-12-08
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-12-08
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-12-08
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2024-12-10
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-12-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-12-08
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-12-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-12-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-12-08
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2024-12-08
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-12-08

Official Correspondent

Yunxia Zhao

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

GAUKE INTERNATIONAL TRADING 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
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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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
3016544015	ARCULANT, INC.	Santa Clara, CA, US
1055890	PRINCETON MEDICAL GROUP, INC.	Franklin, TN, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026263452. Last updated year: 2026. Please use registration number 3026263452 when referencing this establishment in official correspondence.