Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034605486

FEI Number

3034605486

Entity Name

GAUKE (HUBEI) HEALTHCARE CO., LTD

City/State/Country

Huanggang City Hubei, CN

Establishment Address

No. 8, Jiangbei Highway, TuanFeng Town,, Huanggang City Hubei 438000, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Gauke (Hubei) Healthcare Co., Ltd (Owner Number: 10091992)

Owner / Operator Contact Address

No. 8, Jiangbei Highway, TuanFeng Town,, Huanggang City, CN-HB 438000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170393

PMA Number

N/A

All Registered Proprietary Names

Stethoscope Finger cover Cold compress/pack; heat pack Transparent wound dressing; wound dressing; cheat seal splint, wire splint Gauke Brand Splint Roll ADHESIVE TAPE; ROLLER BANDAGE; STERILE ADHESIVE BANDAGE; TRIANGULAR BANDAGE Gauze sponge CPR mask CAT Tourniquet Face mask Cotton ball Cotton Zig-zag cotton roll Cotton roll First Aid Kit First aid dressing bandages BANDAGE COMPRESS; BURN DRESSING; NON-ADHERENT PAD; STERILE ABSORBENT COMPRESS; STERILE GAUZE SWABS Burn Dressing; Burn Gel; Burn Relieve Triangular bandages First Aid Kit EYE COVERING Alcohol prep pad; Pads; povidone iodine prep pads First aid blanket Alcohol pad gloves Gauze sponges, Gauze compress, Gauze swabs, ABD pad, Trauma pad Examination glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-12-03
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-12-02
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-12-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-12-03
LQX	Device, Finger-Sucking	Physical Medicine	Class 1	890.3475	2024-12-03
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-12-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-12-03
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-12-03
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-12-03
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-12-02
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2024-12-02
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-12-02
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-12-10
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2024-12-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-11-22
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-12-03
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-12-03
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-12-02
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-12-10
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-12-03
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-12-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-12-03
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2024-12-10
JTM	Anaerobic Box Glove	Microbiology	Class 1	866.2120	2024-12-03
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-12-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp. Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Gauke (Hubei) Healthcare 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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.

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3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3042481106	SMART HEALTH LLC	Owings Mills, MD, US
3025413691	BESTREAT SAFETY & FIRST AID SOLUTION CO., LTD	Wuhan Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034605486. Last updated year: 2026. Please use registration number 3034605486 when referencing this establishment in official correspondence.