Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004006614

FEI Number

3004006614

Entity Name

GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG

City/State/Country

TELTOW Brandenburg, DE

Establishment Address

ODERSTRASSE 77, TELTOW Brandenburg 14513, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG (Owner Number: 9052369)

Owner / Operator Contact Address

ODERSTRASSE 77, --, TELTOW, DE-NOTA 14513, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122272

PMA Number

N/A

All Registered Proprietary Names

Holter Recorder, Product Code MWJ CardioMem CM 3000-12 BT CardioMem CM 3000-12 BT / SEER 12 CardioDay Holter Evaluation Software CardioDay V2.5 CardioDay v2.6 CardioDay v2.7 Holter Recorder, Product Code MWJ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2013-08-08
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2007-11-05
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-03-29
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2013-04-05

Official Correspondent

Bert Schadow

US Agent Details

Alan P. Schwartz Business: MDI CONSULTANTS, INC. Email: ALAN@MDICONSULTANTS.COM Phone: (516) 4829001

Related Public Records

Same Entity

GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG

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
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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2028530	Datrix LLC	Escondido, CA, US
3012027770	Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC	SHANGHAI, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004006614. Last updated year: 2026. Please use registration number 3004006614 when referencing this establishment in official correspondence.