Data / Medical devices / Taiwan / Sterileright Packaging MFG Inc.
Sterileright Packaging MFG Inc.: FDA-registered device maker in Keelung, Taiwan, 1 510(k) clearance
Sterileright Packaging MFG Inc. is registered with the FDA (registration 3021361802) in Keelung, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021361802
- Address
- 1F, No. 33-7, Dahua 2nd RD., Qidu Dist., Keelung 20653, Taiwan, Keelung, Taiwan, 20653
- Owner or operator
- Sterileright Packaging Mfg Inc. (10083625)
- Roles
- Manufacturer
- First device listed
- December 7, 2021
- Registered through
- 2026
- Brand names listed
- Sterileright
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 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 1, 2021 | K212338 | SterileRight sterilization pouch and roll | FRG | Substantially Equivalent | Sterileright Packaging Mfg., Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 2021. 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.