Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010596279

FEI Number

3010596279

Entity Name

SPELLMAN GMBH

City/State/Country

Bochum North Rhine-Westphalia, DE

Establishment Address

Josef-Baumann-Str. 23, Bochum North Rhine-Westphalia 44805, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spellman GmbH (Owner Number: 10051134)

Owner / Operator Contact Address

Josef-Baumann-Str. 23, Bochum, DE-NW 44805, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EDITOR HFe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2016-02-08

Official Correspondent

Mirco Lukas

US Agent Details

Shalom Cohen Business: Spellman High Voltage Electronics Cooperation Email: scohen@spellmanhv.com Phone: (631) 6303643

Related Public Records

Same Entity

Spellman GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Similar Registrations

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1483291	Varex Imaging Corporation	Franklin Park, IL, US
3007603422	Althea US, Inc.	Goodlettsville, TN, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
1450503	SUMMIT INDUSTRIES, LLC	Niles, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010596279. Last updated year: 2026. Please use registration number 3010596279 when referencing this establishment in official correspondence.