Data / Medical devices / China / Kotex Development Holidings Ltd
Kotex Development Holidings Ltd: FDA-registered device maker in Kowloon, Hong Kong, China, 1 510(k) clearance
Kotex Development Holidings Ltd is registered with the FDA (registration 3002653540) in Kowloon, Hong Kong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002653540
- Address
- Flat C, 3F Fully Ind. Bldg 6 Tsun Yip Lane, Kwun Tong, Kowloon, Hong Kong, China, --
- Owner or operator
- KOTEX DEVELOPMENT HOLDINGS LTD (9068335)
- Roles
- Exporter to the US
- First device listed
- November 17, 2004
- Registered through
- 2026
- Brand names listed
- ALCOHAWAK ELITE, ALCOHAWK MICRO, ALCOHAWK PRECISION, ALCOHAWK SLIM, ALCOHAWK SLIM ULTRA, ALCOHAWK SLIM2, BACtrack Go Breahalyzer BT-KC20, BACtrack Keychain Alcohol Detector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 2005 | K043188 | ALCOHAWK PRECISION | DJZ | Substantially Equivalent | Q3 Innovations, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 9, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.