Data / Medical devices / Taiwan / Aswan International Corporation
Aswan International Corporation: FDA-registered device maker in Taipei, Taiwan, 1 510(k) clearance
Aswan International Corporation is registered with the FDA (registration 3006942545) in Taipei, Taiwan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 3, 1989. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006942545
- Address
- 5F-1, No.102 Roosevelt Road, section 2, Taipei, Taiwan, 100
- Owner or operator
- Aswan International Corporation (10024503)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 7, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Spectacle, Magnifying | HOI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Contract manufacturer, Exporter to the US, 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 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Frame, Spectacle
- All makers of Lens, Spectacle (Prescription), For Reading Discomfort
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Spectacle, Magnifying
- All makers of Mask, Surgical
Updated November 3, 1989. 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.