Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006942548

FEI Number

3006942548

Entity Name

RAUMEDIC - Werk Zwoenitz

City/State/Country

Zwoenitz Saxony, DE

Establishment Address

Am Muehlgraben 10, Zwoenitz Saxony 08297, 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® NEUROMONITORING-SYSTEM RAUMEDIC-ICP-Monitoring-System EM Disposable Stylet RAUMEDIC® -ICP-TEMP-Monitoring-System RAUMEDIC® -ICP-Monitoring-System ventricular BOLT KIT CH9 DRILL KIT CH9 Spliceable Tunneling Sleeve CH8 RAUMEDIC-PTO-Monitoring-System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2025-12-03
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2011-04-06
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-27
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2012-04-18
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2011-11-09
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-11-13

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
3006946348	RAUMEDIC - Muenchberg	Helmbrechts Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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3013944123	Eurofins Infinity Laboratory Group Inc.	San Jose, CA, US
3013886523	Integra LifeSciences Switzerland Sarl	Le Locle Neuchatel, CH
3012507533	Integra Canada ULC	Oakville Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006942548. Last updated year: 2026. Please use registration number 3006942548 when referencing this establishment in official correspondence.