Data / Medical devices / Ireland / Mylan Teoranta
Mylan Teoranta: FDA-registered device maker in Co. Galway Galway(County), Ireland, 1 510(k) clearance
Mylan Teoranta is registered with the FDA (registration 9616674) in Co. Galway Galway(County), Ireland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2014. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616674
- FEI number
- 3002806521
- Address
- Inverin, Co. Galway Galway(County), Ireland, H91H336
- Owner or operator
- Mylan Teoranta (10081157)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 22, 2021
- Registered through
- 2026
- Brand names listed
- Tobi PodManager, Whisperject
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Syringe Needle | KZH | 2 | Manufacturer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 12, 2014 | K141384 | WHISPERJECT AUTOINJECTOR | KZH | Substantially Equivalent | Scandinavian Health Limited | accessdata.fda.gov |
Compare with other makers
Updated September 12, 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.