Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006946348

FEI Number

3006946348

Entity Name

RAUMEDIC - Muenchberg

City/State/Country

Helmbrechts Bavaria, DE

Establishment Address

Hermann-Staudinger Strasse 2, Helmbrechts Bavaria 95233, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RAUMEDIC (Owner Number: 10024509)

Owner / Operator Contact Address

Hermann-Staudinger-Str. 2, Helmbrechts, DE-BY 95233, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RAUMEDIC-PTO-Monitoring-System RAUMEDIC® -ICP-TEMP-Monitoring-System KIRO Set MAJ-1607/1608 MPR2 logO DATALOGGER RAUMEDIC® -ICP-Monitoring-System ventricular BOLT KIT CH9 DRILL KIT CH9 Spliceable Tunneling Sleeve CH8 RAUMEDIC-ICP-Monitoring-System RAUMEDIC® NEUROMONITORING-SYSTEM OrganOx Metra System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-17
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2012-10-17
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-11-13
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2012-04-18
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2015-04-21
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-04-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-08-19
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-02-07
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2017-08-01
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2011-11-09
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2011-04-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-17
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2012-10-17
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2025-12-03
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	Unknown	Class 3	N/A	2022-04-27

Official Correspondent

Hannes Engelhardt

US Agent Details

Jeremy Smith Business: RAUMEDIC Inc. Email: Jeremy.Smith@raumedic.com Phone: (828) 4903262

Related Public Records

Same Entity

RAUMEDIC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012232668	RAUMEDIC, Incorporated.	Mills River, NC, US
3006942548	RAUMEDIC - Werk Zwoenitz	Zwoenitz Saxony, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006946348. Last updated year: 2026. Please use registration number 3006946348 when referencing this establishment in official correspondence.