Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007055152

FEI Number

3007055152

Entity Name

ASKION GMBH

City/State/Country

Gera Thuringia, DE

Establishment Address

Gewerbepark Keplerstr. 17-19, Gera Thuringia 07549, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Askion GmbH (Owner Number: 10092676)

Owner / Operator Contact Address

Gewerbepark Keplerstrasse 17-19, Gera, DE-TH 07549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IC Flow Imaging System 2

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	2026-04-21
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2025-02-05

Official Correspondent

Tina Schlicksbier

US Agent Details

Normand Manning Email: normand.manning@askion.us Phone: (860) 2879001

Related Public Records

Same Entity

Askion GmbH

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007055152. Last updated year: 2026. Please use registration number 3007055152 when referencing this establishment in official correspondence.