Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012885391

FEI Number

3012885391

Entity Name

NUCLEIX LTD.

City/State/Country

Rehovot Central, IL

Establishment Address

3 Pekeris Street, Rehovot Central 7670203, IL

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Nucleix Ltd. (Owner Number: 10088381)

Owner / Operator Contact Address

3 Pekeris Street, Rehovot, IL-M 7670203, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203245

PMA Number

N/A

All Registered Proprietary Names

Bladder EpiCheck

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	Class 2	866.6010	2023-07-12

Official Correspondent

Anna Miller

US Agent Details

Chris Hibbered Business: Nucleix Inc. Email: chris@nucleix.com Phone: (858) 2482137

Related Public Records

Same Entity

Nucleix Ltd.

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 3012885391. Last updated year: 2026. Please use registration number 3012885391 when referencing this establishment in official correspondence.