Data / Medical devices / Taiwan / Heroic Faith International Ltd.
Heroic Faith International Ltd.: FDA-registered device maker in Taipei City, Taiwan, 3 510(k) clearances
Heroic Faith International Ltd. is registered with the FDA (registration 3017829091) in Taipei City, Taiwan. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017829091
- Address
- 18F., No. 460, Sec. 4, Xinyi RD. Xinyi Dist., Taipei City, Taiwan, 110
- Owner or operator
- Heroic Faith International Ltd. (10079026)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 19, 2020
- Registered through
- 2026
- Brand names listed
- AccurSound Electronic Stethoscope AS-101, AccurSound Medical Adhesive Tape (non-sterile), Airmod
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Phonocardiograph | DQC | 1 | Manufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | 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 28, 2025 | K242798 | Airmod | BZQ | Substantially Equivalent | Heroic Faith International , Ltd. | accessdata.fda.gov |
| November 25, 2024 | K242971 | AccurSound Electronic Stethoscope (AS101) | DQD | Substantially Equivalent | Heroic Faith International , Ltd. | accessdata.fda.gov |
| March 23, 2023 | K221805 | AccurSound Electronic Stethoscope AS-101 | DQD | Substantially Equivalent | Heroic Faith International , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Phonocardiograph
- All makers of Stethoscope, Electronic
- All makers of Medical Device Data System
- All makers of Tape And Bandage, Adhesive
- All makers of Monitor, Breathing Frequency
Updated February 28, 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.