Data / Medical devices / Taiwan / Aero Pro Co., Ltd.
Aero Pro Co., Ltd.: FDA-registered device maker in CHANG HUA HSIEN Changhua, Taiwan, 2 510(k) clearances
Aero Pro Co., Ltd. is registered with the FDA (registration 3002691626) in CHANG HUA HSIEN Changhua, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002691626
- Address
- No. 90, Hsin Kung 6 Road Tien Chung Chen, CHANG HUA HSIEN Changhua, Taiwan, 52046
- Owner or operator
- AERO PRO CO., LTD. (9033538)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 7, 2006
- Registered through
- 2026
- Brand names listed
- N95 Surgical Respirator, Oxgen Mask, Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Oxygen | BYG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | 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 |
|---|---|---|---|---|---|---|
| January 8, 2008 | K072067 | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 | MSH | Substantially Equivalent | Shuenn Bao Shing Corporation | accessdata.fda.gov |
| July 12, 1999 | K990719 | EARLOOP FACE MASK | FXX | Substantially Equivalent | Shuenn Bao Shing Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2008. 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.