Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031550429

FEI Number

3031550429

Entity Name

BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI

City/State/Country

Cankaya Ankara, TR

Establishment Address

Universiteler Mah. Ihsan Dogramaci Blv. Satgeb No:23 C, Cankaya Ankara 06800, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRK (Owner Number: 10093622)

Owner / Operator Contact Address

Universiteler Mah. Ihsan Dogramaci Blv. Satgeb No:23 C, Cankaya, TR-06 06800, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233001

PMA Number

N/A

All Registered Proprietary Names

Bioscope Neuromonitor Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-06-13

Official Correspondent

Cemal Erdogan

US Agent Details

Musa YILMAZ Email: biosysfda@gmail.com Phone: (916) 8775853

Related Public Records

Same Entity

BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRK

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
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Similar Registrations

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3009959868	Ferry Machine Corporation	Little Ferry, NJ, US
2024311	PARTER MEDICAL PRODUCTS, INC.	CARSON, CA, US
1048735	STERILIZATION SERVICES OF GEORGIA, INC.	ATLANTA, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031550429. Last updated year: 2026. Please use registration number 3031550429 when referencing this establishment in official correspondence.