Data / Medical devices / Australia / Adherium Limited
Adherium Limited: FDA-registered device maker in Victoria, Australia, 10 510(k) clearances
Adherium Limited is registered with the FDA (registration 3010047139) in Victoria, Australia. It lists 1 device type. The FDA files 10 510(k) clearances under its listings, the newest dated February 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010047139
- Address
- 436 Elgar Road, Box Hill, Victoria, Australia, 3128
- Owner or operator
- Adherium Ltd (10046590)
- Roles
- Manufacturer
- First device listed
- September 24, 2017
- Registered through
- 2026
- Brand names listed
- Hailie Sensor, NF0109, NF0109XL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 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 |
|---|---|---|---|---|---|---|
| February 8, 2023 | K222247 | Hailie Sensor NF0110 | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| October 4, 2022 | K221994 | Hailie Sensor NF0107 & NF0108 | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| July 15, 2022 | K220622 | Hailie Sensor NF0106 | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| August 18, 2021 | K211233 | Hailie Sensor NF0109 | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| June 19, 2019 | K182638 | Hailie Sensor | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| June 7, 2019 | K182573 | Hailie Sensor | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| December 10, 2018 | K181405 | Hailie Sensor | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| July 25, 2018 | K180407 | Smartinhaler | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| March 26, 2018 | K173310 | SmartTouch | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
| August 30, 2017 | K163485 | SmartTouch | CAF | Substantially Equivalent | Adherium (Nz), Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 8, 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.