Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011766844

FEI Number

3011766844

Entity Name

FIDELTRONIK POLAND SP. Z O.O.

City/State/Country

Sucha Beskidzka Malopolskie, PL

Establishment Address

Beniowskiego St. 1, Sucha Beskidzka Malopolskie 32-020, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fideltronik Poland sp. z o.o. (Owner Number: 10095302)

Owner / Operator Contact Address

Beniowskiego St. 1, Sucha Beskidzka, PL-NOTA 32-020, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Natus Natus Natus Natus Natus

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	2026-02-22
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2026-02-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-02-22
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2026-02-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-02-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2026-02-22
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2026-02-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2026-02-22
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2026-02-22
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-02-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-02-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2026-02-22
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2026-02-22
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2026-02-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-02-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2026-02-22
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2026-02-22
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2026-02-22
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2026-02-22
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2026-02-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-02-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2026-02-22
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2026-02-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

Fideltronik Poland sp. z o.o.

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
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24

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.
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
3009959868	Ferry Machine Corporation	Little Ferry, NJ, US
2024311	PARTER MEDICAL PRODUCTS, INC.	CARSON, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011766844. Last updated year: 2026. Please use registration number 3011766844 when referencing this establishment in official correspondence.