Curium US LLC

FDA Device Registration & Listing · Maryland Heights, MO, US · Registration 3011353845

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
3011353845
FEI Number
1946929
Entity Name
Curium US LLC
City/State/Country
Maryland Heights, MO, US
Establishment Address
2703 Wagner Pl, Maryland Heights, MO 63043, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Curium US LLC (Owner Number: 10051585)
Owner / Operator Contact Address
2703 Wagner Place, Maryland Heights, MO 63043, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K843640
PMA Number
N/A

All Registered Proprietary Names

Xenotron Xenon (Xe 133) Gas Dispenser

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYT System, Rebreathing, Radionuclide Radiology Class 2 892.1390 2016-04-07

Official Correspondent

Amit Jain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Curium US LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9610348 Curium Netherlands B.V. Petten Noord-Holland, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011353845. Last updated year: 2026. Please use registration number 3011353845 when referencing this establishment in official correspondence.
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