Data / Medical devices / Estonia / Pharma Systems Eesti OU
Pharma Systems Eesti OU: FDA-registered device maker in Riidakula Hiiumaa, Estonia, 4 510(k) clearances
Pharma Systems Eesti OU is registered with the FDA (registration 3010877292) in Riidakula Hiiumaa, Estonia. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010877292
- Address
- Parma, Riidakula Hiiumaa, Estonia, 92020
- Owner or operator
- Pharma Systems Eesti OU (10048263)
- Roles
- Manufacturer
- First device listed
- December 22, 2014
- Registered through
- 2026
- Brand names listed
- Bact Trap Midi, Bact-HME, Bact-HME Midi, Bact-HME Port, Bact-Trap, Bact-Trap Mini, HME 10, HME 11 MDI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 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 |
|---|---|---|---|---|---|---|
| September 26, 2021 | K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter | CAH | Substantially Equivalent | Pharma System AB | accessdata.fda.gov |
| November 9, 1990 | K903058 | BACT-HME (TM) | BYD | Substantially Equivalent | Pharma Systems, Inc. | accessdata.fda.gov |
| November 5, 1990 | K903056 | BACTTRAP | CAH | Substantially Equivalent | Pharma Systems, Inc. | accessdata.fda.gov |
| October 31, 1990 | K903054 | HME-10 (TM) | BYD | Substantially Equivalent | Pharma Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Condenser, Heat And Moisture (Artificial Nose)
Updated September 26, 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.