Data / Medical devices / New Zealand / Medella Health Ltd
Medella Health Ltd: FDA-registered device maker in Tauranga Bay of Plenty, New Zealand, 1 510(k) clearance
Medella Health Ltd is registered with the FDA (registration 3016472144) in Tauranga Bay of Plenty, New Zealand. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016472144
- Address
- 7/144 Third Ave, Tauranga Bay of Plenty, New Zealand, 3110
- Owner or operator
- Medella Health Ltd (10090693)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 29, 2024
- Registered through
- 2026
- Brand names listed
- Flowpresso
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| December 21, 2023 | K223729 | FLOWpresso | IRP | Substantially Equivalent | Medella Health Limited | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2023. 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.