Data / Medical devices / Poland / DGS Diagnostics Sp. z o.o

DGS Diagnostics Sp. z o.o: FDA-registered device maker in Kolbaskowo Zachodniopomorskie, Poland, 12 510(k) clearances

Name: DGS Diagnostics Sp. z o.o FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DGS Diagnostics Sp. z o.o is registered with the FDA (registration 3011310592) in Kolbaskowo Zachodniopomorskie, Poland. It lists 26 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 24, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011310592
Address: Rosowek 43, Kolbaskowo Zachodniopomorskie, Poland, 72-001
Owner or operator: DEMANT A/S (8010048)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
First device listed: September 21, 1994
Registered through: 2026
Brand names listed: 2D-VOG Goggles, 2D-VOG System, 2D-VOGfw, AA222, ABRIS, AC 440 Module, AC33, AC40 and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Vestibular Analysis	LXV	U	Contract manufacturer	accessdata.fda.gov
Audiometer	EWO	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Hearing Aid / Earphone And Analysis Systems	ETW	2	Contract manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Curette, Ear	JYG	1	Exporter to the US	accessdata.fda.gov
Cushion, Earphone (For Audiometric Testing)	ETT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Forceps, Ent	KAE	1	Exporter to the US	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Exporter to the US	accessdata.fda.gov
Media, Electroconductive	GYB	2	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Contract manufacturer	accessdata.fda.gov
Nystagmograph	GWN	2	Contract manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Rhinoanemometer (Measurement Of Nasal Decongestion)	BXQ	2	Contract manufacturer	accessdata.fda.gov
Set, Audiometer Calibration	EWA	1	Contract manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Exporter to the US	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Caloric-Air	KHH	1	Contract manufacturer	accessdata.fda.gov
Stimulator, Caloric-Water	ETP	1	Contract manufacturer	accessdata.fda.gov
Syringe, Ent	KCP	1	Exporter to the US	accessdata.fda.gov
Tester, Auditory Impedance	ETY	2	Contract manufacturer	accessdata.fda.gov
Tester, Auditory Impedance, Exempt	PTO	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Tympanometer	NAS	2	Contract manufacturer	accessdata.fda.gov
Tympanometer, Exempt	PTP	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 24, 2020	K193033	GSI Audera Pro	GWJ	Substantially Equivalent	Grason Stadler	accessdata.fda.gov
July 15, 2019	K191372	Lyra	EWO	Substantially Equivalent	Interacoustics A/S	accessdata.fda.gov
February 14, 2018	K173567	Sera	EWO	Substantially Equivalent	Interacoustics A/S	accessdata.fda.gov
October 20, 2017	K172403	GSI Novus	EWO	Substantially Equivalent	Grason-Stadler, Inc.	accessdata.fda.gov
August 29, 2017	K171506	Easyscreen	EWO	Substantially Equivalent	Maico Diagnostics GmbH	accessdata.fda.gov
January 29, 2009	K082035	MAICO MB 11 WITH BERAPHONE PROBE	GWJ	Substantially Equivalent	Maico Diagnostics	accessdata.fda.gov
June 29, 2007	K070696	INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)	GWJ	Substantially Equivalent	Interacoustics A/S	accessdata.fda.gov
June 23, 2006	K060883	PILOT TEST OR DETECTIVE AUDIOMETERS	EWO	Substantially Equivalent	Interacoustics A/S	accessdata.fda.gov
August 24, 2001	K011746	MB 11	GWJ	Substantially Equivalent	Maico Diagnostic GmbH	accessdata.fda.gov
May 3, 2001	K010638	NEUROPLUS, MODEL A10040, A10041, A10042, A10043	GXY	Substantially Equivalent	Vermont Medical, Inc.	accessdata.fda.gov
September 29, 1993	K930553	CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT	EWO	Substantially Equivalent	Etymotic Research	accessdata.fda.gov
September 28, 1988	K883149	TEN20 CONDUCTIVE	GYB	Substantially Equivalent	Weaver & Co.	accessdata.fda.gov

Compare with other makers

Updated April 24, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.