Data / Medical devices / China / Comepa Industries Limited
Comepa Industries Limited: FDA-registered device maker in Hongkong Hong Kong, China, 1 510(k) clearance
Comepa Industries Limited is registered with the FDA (registration 3021602003) in Hongkong Hong Kong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021602003
- Address
- 21/F On Hing Building, On Hing Terrace, Central, Hongkong Hong Kong, China, 000000
- Owner or operator
- COMEPA INDUSTRIES LIMITED (10083870)
- Roles
- Exporter to the US
- First device listed
- December 27, 2021
- Registered through
- 2026
- Brand names listed
- Adhesive Electrodes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | 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 |
|---|---|---|---|---|---|---|
| October 6, 2021 | K212191 | Adhesive Electrodes | GXY | Substantially Equivalent | Voncare Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 6, 2021. 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.