Data / Medical devices / Turkey / Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti
Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti: FDA-registered device maker in Izmir, Turkey, 5 510(k) clearances
Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti is registered with the FDA (registration 3008045828) in Izmir, Turkey. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 30, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008045828
- Address
- Zafer SB MAh Gunduz Sk No:13 Ege Serbest Bolge Gaziemir IZmir, Izmir, Turkey, 35620
- Owner or operator
- Lansinoh Laboratories Saglik Ger. Tas. San. Tic. Ltd. Sti. (10030867)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- November 24, 2009
- Registered through
- 2026
- Brand names listed
- Affinity Double Electr Breast Pump, Compact Wearable Pump, Contact Nipple Shields 16mm, Contact Nipple Shields 20mm, Contact Nipple Shields 24mm, Lansinoh Manual Breast Pump, NaturalWave Double Electric Breast Pump, Primo-Lacto Ameda Enfit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 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 |
|---|---|---|---|---|---|---|
| June 30, 2023 | K230469 | Compact Wearable Pump | HGX | Substantially Equivalent | Lansinoh Laboratories | accessdata.fda.gov |
| December 23, 2022 | K222726 | Smartpump 3.0 Double Electric Breast Pump | HGX | Substantially Equivalent | Lansinoh Laboratories | accessdata.fda.gov |
| June 12, 2019 | K182749 | Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump | HGX | Substantially Equivalent | Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. | accessdata.fda.gov |
| December 28, 2012 | K122474 | LANSINOH POWERED ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Lansinoh Laboratories Saglik Gerecleri Tasarim San | accessdata.fda.gov |
| October 22, 2009 | K092783 | DEBP | HGX | Substantially Equivalent | Enko , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Pump, Breast, Non-Powered
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated June 30, 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.