Data / Medical devices / Israel / Annabella Tech
Annabella Tech: FDA-registered device maker in Kfar Saba Central, Israel, 2 510(k) clearances
Annabella Tech is registered with the FDA (registration 3029923636) in Kfar Saba Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029923636
- Address
- 23/5 Hataas, Kfar Saba Central, Israel, 4442525
- Owner or operator
- Annabella Tech (10088803)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 12, 2023
- Registered through
- 2026
- Brand names listed
- Annabella Breast Pump, Annabella Double Breast Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, Specification developer | 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 27, 2024 | K241506 | Annabella Double Breast Pump (ADO-US23-1000) | HGX | Substantially Equivalent | Annabella Tech | accessdata.fda.gov |
| August 4, 2023 | K230672 | Annabella Breast Pump | HGX | Substantially Equivalent | Annabella , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 27, 2024. 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.