Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001744144

FEI Number

3001744144

Entity Name

PAR MEDIZINTECHNIK GMBH & Co. KG

City/State/Country

BERLIN, DE

Establishment Address

Rigistr. 11, BERLIN D-12277, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PAR MEDIZINTECHNIK GMBH & Co. KG (Owner Number: 9046872)

Owner / Operator Contact Address

Rigistr. 11, --, BERLIN, DE-BE D-12277, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012647

PMA Number

N/A

All Registered Proprietary Names

TONOPORT VI TONOPORT V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2021-05-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-12-14
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2021-05-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2007-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

PAR MEDIZINTECHNIK GMBH & Co. KG

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
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001744144. Last updated year: 2026. Please use registration number 3001744144 when referencing this establishment in official correspondence.