Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014321789

FEI Number

3014321789

Entity Name

XIRALITE GMBH

City/State/Country

Berlin, DE

Establishment Address

Robert-Koch-Platz 4, Berlin 10115, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiralite GmbH (Owner Number: 10056880)

Owner / Operator Contact Address

Robert-Koch-Platz 4, Berlin, DE-BE 10115, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130003

PMA Number

N/A

All Registered Proprietary Names

XIRALITE FLOURESCENCE IMAGING SYSTEM X4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2018-01-26
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2018-01-26

Official Correspondent

Miroslava Racheva

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

Xiralite GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24
K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit	2025-02-19

Similar Registrations

Registration Number	Establishment Name	Location
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3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
3009057691	LIFE SCIENCE LOGISTICS, LLC	Brownsburg, IN, US
3012127758	Siemens Healthcare Limited	Oakville Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014321789. Last updated year: 2026. Please use registration number 3014321789 when referencing this establishment in official correspondence.