Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010362364

FEI Number

3010362364

Entity Name

BEMOTEC GMBH

City/State/Country

Sonnenbühl Baden-Wurttemberg, DE

Establishment Address

Drosselstr. 13, Sonnenbühl Baden-Wurttemberg 72820, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BEMOTEC GmbH (Owner Number: 10043343)

Owner / Operator Contact Address

Drosselstr. 13, Sonnenbühl, DE-BW 72820, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-12-12
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2014-12-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-12
JEY	Plate, Bone	Dental	Class 2	872.4760	2013-02-07
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2014-12-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-12-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-12-12

Official Correspondent

Birgit Herrmann

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

BEMOTEC 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
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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

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.

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3009108888	RENISHAW MAYFIELD	Chassieu Rhone, FR
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
2434444	NEURODYNAMICS, INC.	Manhattan, NY, US
3017004815	RENISHAW NEURO SOLUTIONS LTD	Wotton-under-Edge Gloucestershire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010362364. Last updated year: 2026. Please use registration number 3010362364 when referencing this establishment in official correspondence.