XEOS MEDICAL

FDA Device Registration & Listing · Sint-Denijs-Westrem Oost-Vlaanderen, BE · Registration 3027847687

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027847687
FEI Number
3027847687
Entity Name
XEOS MEDICAL
City/State/Country
Sint-Denijs-Westrem Oost-Vlaanderen, BE
Establishment Address
Kortrijksesteenweg 1084 bus 301, Sint-Denijs-Westrem Oost-Vlaanderen 9051, BE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
XEOS Medical (Owner Number: 10088583)
Owner / Operator Contact Address
Kortrijksesteenweg 1084 bus 301, Sint-Denijs-Westrem, BE-VOV 9051, BE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231420
PMA Number
N/A

All Registered Proprietary Names

AURA 10 PET CT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MWP Cabinet, X-Ray System Radiology Class 2 892.1680 2023-08-21
QXL Cabinet, Emission Computed Tomography System Radiology Class 2 892.1200 2023-08-21

Official Correspondent

Agnieszka Swiatek

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

XEOS Medical
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 3027847687. Last updated year: 2026. Please use registration number 3027847687 when referencing this establishment in official correspondence.
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