Data / Medical devices / Australia / Daniels Corporation International Pty Ltd
Daniels Corporation International Pty Ltd: FDA-registered device maker in Dandenong South Victoria, Australia, 2 510(k) clearances
Daniels Corporation International Pty Ltd is registered with the FDA (registration 9613648) in Dandenong South Victoria, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613648
- FEI number
- 3003045637
- Address
- Lot 2 Unit 2 533 Frankston- Dandenong Rd, Dandenong South Victoria, Australia, 3175
- Owner or operator
- Daniels Corporation International Pty Ltd (10042527)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 5, 2012
- Registered through
- 2026
- Brand names listed
- Bladesafe, Ecoship, S Series Sharpsmart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 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 |
|---|---|---|---|---|---|---|
| January 31, 2014 | K132792 | ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER | MMK | Substantially Equivalent | Daniels Sharpsmart, Inc. | accessdata.fda.gov |
| July 5, 2000 | K001337 | DANIELS SHARPSMART REUSABLE SHARPS CONTAINER | MMK | Substantially Equivalent | The Daniels Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2014. 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.