Gaboss International Limited
Registered establishment in Kowloon, Xinjiang, China. 9 device types.
Gaboss International Limited is a manufacturer holding a current FDA establishment registration. The registration covers Non-Surgical Gown, Scaler, Periodontic and 7 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | GABOSS INTERNATIONAL LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015501220 |
| FEI number | 3015501220 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 嘉伯士國際有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Kowloon |
|---|---|
| Province | Xinjiang |
| Address | 19H MAXGRAND PLAZA NO.3 TAI YAU STREET SAN PO KONG |
| Postal code | 999077 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | mask | 2020 | 439 |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | Class 1 | Wearable Milk Collector, Freestyle Flex Connector | 2023 | 10 |
| Massager, Therapeutic, Electric | Class 1 | Massage Gun, massage chair, Warming Lactation Massager | 2020 | 437 |
| Non-Surgical Gown | Class 1 | mask | 2020 | 318 |
| Nursing Pad, Cohesive Gel | Class 1 | Silver Nursing Cups | 2023 | 9 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | portable steam sauna tent | 2024 | 45 |
| Pad, Heating, Powered | Class 2 | sauna blanket | 2024 | 144 |
| Pump, Breast, Powered | Class 2 | Breast Pump | 2023 | 40 |
| Scaler, Periodontic | Class 1 | tooth cleaner | 2024 | 34 |
Clearances
No clearance names Gaboss International Limited as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222782 | 2023-01-13 | HGX | Traditional | Zhejiang Carebao Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Medical Distribution Industries, Ltd. | 27 |
| Ming FAI Enterprise International Co., Ltd. | 18 |
| Sunstar Trading International Limited | 6 |
| Sunrise Dental Laboratory, Ltd. | 5 |
| Polygreen (HK) Co., Ltd. | 4 |
| P. Gopaldas Ltd. | 2 |
| Daka International Limited | 2 |
| Profit Royal Pharmaceutical Limited | 2 |
| Kotex Development Holidings Ltd | 1 |
| Polystar Technology Development Limited | 1 |
| HK Damisen Technology Co., Limited | 1 |
| Mega Trade International Industrial Ltd | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.