Siemens Healthcare GmbH

FDA Device Registration & Listing · Berlin, DE · Registration 3011194542

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
3011194542
FEI Number
3011194542
Entity Name
Siemens Healthcare GmbH
City/State/Country
Berlin, DE
Establishment Address
Am Studio 1, Berlin 12489, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)
Owner / Operator Contact Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2000-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

Felix Akinrinola Business: Siemens Healthcare Diagnostics Inc. Email: felix.akinrinola@siemens-healthineers.com Phone: (781) 8561738

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012817228 Epocal Inc Ottawa Ontario, CA
3009448641 Siemens Healthcare Diagnostics, Inc. Mishawaka, IN, US
3004959793 EPOCAL, INC. Ottawa Ontario, CA
9610633 SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD SUDBURY Suffolk, GB
3002637618 Siemens Healthcare Diagnostics Inc East Walpole, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use
Z-0026-2025 Becton Dickinson & Co. 1
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011194542. Last updated year: 2026. Please use registration number 3011194542 when referencing this establishment in official correspondence.
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