Data / Medical devices / Israel / Gerium Medical Ltd
Gerium Medical Ltd: FDA-registered device maker in Yavne Central, Israel, 1 510(k) clearance
Gerium Medical Ltd is registered with the FDA (registration 3042972073) in Yavne Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042972073
- Address
- 4 Paran St., Building 11, Yavne, Israel., Yavne Central, Israel, 8122503
- Owner or operator
- Gerium (10094882)
- Roles
- Manufacturer
- First device listed
- January 14, 2026
- Registered through
- 2026
- Brand names listed
- BiliWrap Phototherapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Neonatal Phototherapy | LBI | 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 |
|---|---|---|---|---|---|---|
| May 29, 2025 | K243372 | BiliWrap | LBI | Substantially Equivalent | Gerium Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 29, 2025. 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.