Data / Medical devices / Taiwan / BESMED HEALTH BUSINESS CORP.-Chiayi
BESMED HEALTH BUSINESS CORP.-Chiayi: FDA-registered device maker in Dalin Township Chiayi(County), Taiwan, 3 510(k) clearances
BESMED HEALTH BUSINESS CORP.-Chiayi is registered with the FDA (registration 3021284283) in Dalin Township Chiayi(County), Taiwan. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 14, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021284283
- Address
- No. 42, Dapumeiyuanqu 3rd Rd., Dalin Township Chiayi(County), Taiwan, 622011
- Owner or operator
- BESMED HEALTH BUSINESS CORP. (9047866)
- Roles
- Manufacturer
- First device listed
- June 26, 2007
- Registered through
- 2026
- Brand names listed
- BESMED BERMAN, Besmed Bacterial Filter and HMEF, Besmed TriBall Incentive Spirometer, Besmed Volumetric Incentive Spirometer, Besmed silicone drainage system, GUEDEL AIRWAY, LARYNGEAL AIRWAY MASK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Irrigation | GBQ | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 14, 2024 | K241339 | Besmed Bacterial Filter and HMEF | CAH | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| September 3, 2014 | K141355 | VOLUMETRIC INCENTIVE SPIROMETER | BWF | Substantially Equivalent | Besmed Health Business Corporation | accessdata.fda.gov |
| April 4, 2014 | K133873 | TRIBALL INCENTIVE SPIROMETER | BWF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Catheter, Continuous Irrigation
- All makers of Spirometer, Therapeutic (Incentive)
Updated November 14, 2024. 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.