FDA Registration
Active
🇨🇳 China
GAUKE INTERNATIONAL TRADING CO., LTD.
Reg #: 3026263452
·
FEI: 3026263452
·
Expires 2026
Products
32
Proprietary Names
57
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- GAUKE INTERNATIONAL TRADING CO., LTD.
- Registration Number
- 3026263452
- FEI Number
- 3026263452
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROOM 201-1, BUILDING 8, NO.10 FENGSHUO ROAD, QIAOKOU DISTRICT
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K170393
Owner / Operator
- Firm Name
- GAUKE INTERNATIONAL TRADING CO., LTD.
- Operator Number
- 10092137
- Address
- ROOM 201-1, BUILDING 8, NO.10 FENGSHUO ROAD, QIAOKOU DISTRICT
- City
- Wuhan
- State
- Hubei
- Postal Code
- 430035
- Country
- CN
- Correspondent
- Yunxia Zhao
US Agent
- Business Name
- LLINS TECHNOLOGY INC
- Contact Name
- James Wang
- Address
- 1312 17th street Unit #2199
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 720 2171916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2024-12-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-12-08 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2024-12-08 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-12-08 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2024-12-08 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2024-12-10 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-12-08 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2024-12-08 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2024-12-08 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2024-12-08 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2024-12-08 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2024-12-08 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2024-12-08 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-12-10 |
| Anaerobic Box Glove | JTM | Class 1 | Microbiology | No | 2024-12-08 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-12-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-12-10 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2024-12-08 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2024-12-08 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2024-12-08 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
| Device, Finger-Sucking | LQX | Class 1 | Physical Medicine | No | 2024-12-08 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2026-04-08 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-12-08 |
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
First Aid Kit With Drug
Gloves
Eye Covering
Conforming Elastic Bandages
Crepe Bandages
Gauze Sponges
Abd Pad
Trauma Pad
Gauze Compress
Gauze Swabs
First Aid Kit
Antiseptic Wipes
Antiseptic Towelette
Mask, Oxygen
Non-Adherent Pad
Bandage Compress
Sterile Absorbent Compress
Sterile Gauze Swabs
CAT Tourniquet
Splint, Wire Splint
Examination glove
Drape
Hand Towel
Face Shield
Shoe Cover
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device