Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018182832

FEI Number

3018182832

Entity Name

SCOPIO LABS LTD.

City/State/Country

Tel Aviv, IL

Establishment Address

10 Hasharon St., Tel Aviv 6618502, IL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Scopio Labs Ltd. (Owner Number: 10080474)

Owner / Operator Contact Address

10 Hasharon St., Tel Aviv, IL-TA 6618502, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220013

PMA Number

N/A

All Registered Proprietary Names

X100 / X100HT with Full Field Peripheral Blood Smear (PBS) Application X100 with Full Field Peripheral Blood Smear (PBS) Application X100HT with Full Field Peripheral Blood Smear (PBS) Application

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2025-07-30
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2021-02-04
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2022-11-11

Official Correspondent

Amy Meitus

US Agent Details

Itai Hayut Business: Scopio Labs Inc. Email: itai@scopiolabs.com Phone: (203) 6925021

Related Public Records

Same Entity

Scopio Labs 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 3018182832. Last updated year: 2026. Please use registration number 3018182832 when referencing this establishment in official correspondence.