FDA Registration
Active
🇨🇳 China
GABOSS INTERNATIONAL LIMITED
Reg #: 3015501220
·
FEI: 3015501220
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- GABOSS INTERNATIONAL LIMITED
- Registration Number
- 3015501220
- FEI Number
- 3015501220
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19H MAXGRAND PLAZA NO.3 TAI YAU STREET SAN PO KONG
- City
- KOWLOON Xinjiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222782
Owner / Operator
- Firm Name
- GABOSS INTERNATIONAL LIMITED
- Operator Number
- 10062777
- Address
- 19H MAXGRAND PLAZA NO.3 TAI YAU STREET SAN PO KONG
- City
- KOWLOON
- State
- Xinjiang
- Postal Code
- 999077
- Country
- CN
- Correspondent
- Jian Zhang
US Agent
- Business Name
- 762
- Contact Name
- Jinxiu Luo
- Address
- 839 FM 1489 Road
- City
- Brookshire
- State
- TX
- ZIP
- 77423
- Country
- US
- [email protected]
- Phone
- 762 2222081
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2023-02-26 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-07 |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | Class 1 | Obstetrics/Gynecology | No | 2023-02-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-07 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2020-03-07 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2024-05-09 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2023-02-26 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2024-04-27 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2024-05-09 |
Proprietary Names
Silver Nursing Cups
mask
Freestyle Flex Connector
Wearable Milk Collector
Massage Gun
Warming Lactation Massager
massage chair
sauna blanket
Breast Pump
tooth cleaner
portable steam sauna tent
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device