Data / Medical devices / Turkey / Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.: FDA-registered device maker in Tire Izmir, Turkey, 7 510(k) clearances
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. is registered with the FDA (registration 3006534321) in Tire Izmir, Turkey. It lists 22 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 7, 2022. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006534321
- Address
- Ibni Melek Mah. Organize Sanayi Bolgesi, Tire Izmir, Turkey, 35900
- Owner or operator
- Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. (9099982)
- Roles
- Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 5, 2007
- Registered through
- 2027
- Brand names listed
- 005060 22 MM BREATHING CIRCUIT / LEAK PORT, 005519- 15mm Dual Limb Breathing Circuit, 005520- 22mm Dual Limb Breathing Circuit, 007387 22MM DISPOSABLE BREATHING CIRCUIT WITH EXHALATION VALVE, 007616 IPBB BREATHING CIRCUIT (BREAS), 007857 15 MM DISP PT CIRCUIT W EX VAL, 009118 Disposable 22mm Single Limb (1.8m), 009119 Disposable 15mm Single Limb (1.8m) and more
Devices it lists
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 7, 2022 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | CAH | Substantially Equivalent | Drägerwerk AG & Co. KGaA | accessdata.fda.gov |
| March 16, 2020 | K192713 | Altera Filter and HME/Filter | CAH | Substantially Equivalent | Meditera Tibbi Malzeme San VE Tic AS | accessdata.fda.gov |
| January 17, 2020 | K192563 | Altera gas Sampling Lines | CCK | Substantially Equivalent | Meditera Tibbi Malzeme San VE Tic AS | accessdata.fda.gov |
| December 11, 2014 | K141389 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| August 5, 2014 | K141834 | SAPPHIRE ADMINISTRATION SET | FPA | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| October 17, 2013 | K123049 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| September 13, 2011 | K102483 | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 | CAH | Substantially Equivalent | Sunset Healthcare Solutions, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Accessories, Pump, Infusion
- All makers of Pump, Infusion
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Filter, Bacterial, Breathing-Circuit
Updated December 7, 2022. 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.