Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006113127

FEI Number

3006113127

Entity Name

CNSYSTEMS MEDIZINTECHNIK GmbH

City/State/Country

Graz Steiermark, AT

Establishment Address

REININGHAUSSTRASSE 13, Graz Steiermark A-8020, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CNSystems Medizintechnik GmbH (Owner Number: 9088754)

Owner / Operator Contact Address

Reininghausstrasse 13, GRAZ, STYRIA, AT-6 A-8020, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183521

PMA Number

N/A

All Registered Proprietary Names

CNAP Monitor 500at CNAP Monitor 500i Task Force CORE TASK FORCE MONITOR 3040 CNAP Monitor 500 HD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-12-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-06-02
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2006-06-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-10-09

Official Correspondent

Raphael Gunacker

US Agent Details

Peter Hasslacher Email: newyork@wko.at Phone: (212) 4215250

Related Public Records

Same Entity

CNSystems Medizintechnik 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

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3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006113127. Last updated year: 2026. Please use registration number 3006113127 when referencing this establishment in official correspondence.