Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042972073

FEI Number

3042972073

Entity Name

Gerium Medical Ltd

City/State/Country

Yavne Central, IL

Establishment Address

4 Paran St., Building 11, Yavne, Israel., Yavne Central 8122503, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gerium (Owner Number: 10094882)

Owner / Operator Contact Address

P.O Box 13271, 4 Paran St., Building 11, Yavne, Israel., Yavne, IL-M 8122503, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243372

PMA Number

N/A

All Registered Proprietary Names

BiliWrap Phototherapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2026-01-14

Official Correspondent

Noam Rubin Tal

US Agent Details

Tiffany Shin Business: SUNG KWON Email: ask@provisionfda.com Phone: (909) 4933276

Related Public Records

Same Entity

Gerium

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042972073. Last updated year: 2026. Please use registration number 3042972073 when referencing this establishment in official correspondence.