Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000275399

FEI Number

3000275399

Entity Name

Siemens Healthineers AG

City/State/Country

RUDOLSTADT Thuringia, DE

Establishment Address

RONTGENSTRASSE 2, RUDOLSTADT Thuringia 07407, DE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Siemens Healthineers AG (Owner Number: 8010024)

Owner / Operator Contact Address

Karlheinz-Kaske-Str. 5, --, Erlangen, DE-NOTA 91052, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SMB Family Opti Family Athlon Family RAY Family SIREPHOS Family OPTIPHOS Family Gigalix Family Megalix Cat Family S3P-Monoblock TR Family Megalix Family Megalix Cat Plus Family P40 MoW-100G Vectron Family CHRONON Family DURA Family Optilix Family STRATON Family Optitop Family Angiolux Family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2003-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Phillips Business: SIEMENS MEDICAL SOLUTIONS USA, INC. Email: robert.z.phillips@siemens-healthineers.com Phone: (302) 2359839

Related Public Records

Same Entity

Siemens Healthineers AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3033524690	VUZE MEDICAL LTD.	TEL AVIV-JAFFA, IL
3011569702	SIEMENS X-RAY VACUUM TECHNOLOGY LTD.	Wuxi Jiangsu, CN
3002808157	Siemens Healthineers AG	ERLANGEN Bavaria, DE
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3003202425	SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.	SHANGHAI, CN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000275399. Last updated year: 2026. Please use registration number 3000275399 when referencing this establishment in official correspondence.