Kotex Development Holidings Ltd
Registered establishment in Kowloon, Hong Kong, China. 1 device type.
Kotex Development Holidings Ltd is an exporter holding a current FDA establishment registration. The registration covers Devices, Breath Trapping, Alcohol. Its earliest product listing with the FDA dates from 2004.
Registration
| Registered name | KOTEX DEVELOPMENT HOLIDINGS LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3002653540 |
| FEI number | 3002653540 |
| Establishment type | Exporter |
Location
| City | Kowloon |
|---|---|
| Province | Hong Kong |
| Address | Flat C, 3F Fully Ind. Bldg |
| Postal code | — |
| Country | China |
Group
Kotex Development Holidings Ltd is one of 2 plants registered under KOTEX DEVELOPMENT HOLDINGS LTD.
| Plant | City | Device types |
|---|---|---|
| Sunton Electronics Co., Ltd. | Heyuan | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | Class 1 | BTM-KC20-CS-NFC, BTM-KC10-PK-NFC, BTM-KC20-2P-NFC, BTM-KC10-BL-NFC, BT-KC20, BT-KC10 GN and 29 more | 2004 | 16 |
Clearances
No clearance names Kotex Development Holidings Ltd 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 |
|---|---|---|---|---|
| K043188 | 2005-02-09 | DJZ | Traditional | Q3 Innovations, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1988 |
|---|---|
| Main products | Breathalyzer, Alcohol tester, Personal healthcare safety products |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Medical Distribution Industries, Ltd. | 27 |
| Ming FAI Enterprise International Co., Ltd. | 18 |
| Gaboss International Limited | 9 |
| 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 |
| 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.