MedFact Engineering GmbH

FDA Device Registration & Listing · Loerrach Baden-Wurttemberg, DE · Registration 3008497357

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008497357
FEI Number
3008497357
Entity Name
MedFact Engineering GmbH
City/State/Country
Loerrach Baden-Wurttemberg, DE
Establishment Address
Hammerstr. 3, Loerrach Baden-Wurttemberg 79540, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
MEDFACT ENGINEERING GMBH (Owner Number: 10045544)
Owner / Operator Contact Address
Hammerstrasse 3, Loerrach, DE-BW 79540, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

7F PV Catheters 4F PV Catheters EasyMap MAP EProC Esophageal Retractor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-04-10
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-04-10
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-06
GAD Retractor General, Plastic Surgery Class 1 878.4800 2016-12-06

Official Correspondent

JOERG REINHARDT

US Agent Details

Melissa Walker Business: Graematter, Inc Email: mwalker@graematter.com Phone: (636) 4057498

Related Public Records

Same Entity

MEDFACT ENGINEERING 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
K251211 ABBOTT MEDICAL ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ 2025-05-23
K251231 ABBOTT MEDICAL ViewFlex™ X ICE Catheter, Sensor Enabled™ 2025-05-20
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2016 Biosense Webster, Inc. 2
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number Establishment Name Location
3013844297 DANELIS MEDICAL LIMITED Rhayader Powys, GB
1058584 Sterigenics US LLC Charlotte, NC, US
3017894900 Philips Ultrasound LLC Cambridge, MA, US
3015859709 Arrow International, LLC (subsidiary of Teleflex Incorporated) Wyomissing, PA, US
3019216 Philips Ultrasound LLC BOTHELL, WA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008497357. Last updated year: 2026. Please use registration number 3008497357 when referencing this establishment in official correspondence.
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