Data / Medical devices / Taiwan / Hcmed Innovations Co., Ltd.
Hcmed Innovations Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Hcmed Innovations Co., Ltd. is registered with the FDA (registration 3016750005) in New Taipei City, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016750005
- Address
- 2F., No.166, Jiankang Rd. Zhonghe Dist., New Taipei City, Taiwan, 23585
- Owner or operator
- HCMed Innovations Co., Ltd. (10082903)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 19, 2021
- Registered through
- 2026
- Brand names listed
- AdheResp, Aerogen Go AC/DC Adapter, Aerogen Go Medication Reservoir, Aerogen Go Vibrating Mesh Nebulizer, Aerogen Go Vibrating Mesh Nebulizer, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Oxygen | BYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 20, 2025 | K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | CAF | Substantially Equivalent | Hcmed Innovations Co., Ltd. | accessdata.fda.gov |
| July 1, 2021 | K202171 | Pulmogine Vibrating Mesh Nebulizer | CAF | Substantially Equivalent | Hcmed Innovations Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Mouthpiece, Breathing
- All makers of Mask, Oxygen
Updated June 20, 2025. 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.