FDA Registration Active 🇵🇱 Poland

DGS Diagnostics Sp. z o.o

Reg #: 3011310592 · FEI: 3011310592 · Expires 2026
Products
26
Proprietary Names
243
Establishment Types
4
Classifications
26

Registration Details

Registration Name
DGS Diagnostics Sp. z o.o
Registration Number
3011310592
FEI Number
3011310592
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rosowek 43
City
Kolbaskowo Zachodniopomorskie
Country
PL

Regulatory Submissions

510(k) Number
K010638

Owner / Operator

Firm Name
DEMANT A/S
Operator Number
8010048
Address
KONGEBAKKEN 9, --
City
SMORUM
State
DK-NOTA
Postal Code
DK-2765
Country
DK

US Agent

Business Name
Grason-Stadler
Contact Name
Brandon Bell
Address
10395 West 70th Street
City
Eden Prairie
State
MN
ZIP
55344
Country
US
Phone
952 9476097

Products

Device Name Product Code
Electrode, Cutaneous GXY
Apparatus, Vestibular Analysis LXV
Tester, Auditory Impedance ETY
Catheter And Tip, Suction JOL
Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
Nystagmograph GWN
Audiometer EWO
Stimulator, Auditory, Evoked Response GWJ
Stimulator, Caloric-Water ETP
Forceps, Ent KAE
Cable, Electrode IKD
Syringe, Ent KCP
Otoscope ERA
Curette, Ear JYG
Tympanometer, Exempt PTP
Tympanometer NAS
Speculum, Ent EPY
Electrode, Electrocardiograph DRX
Stimulator, Caloric-Air KHH
Cushion, Earphone (For Audiometric Testing) ETT
Instrument, Ent Manual Surgical LRC
Set, Audiometer Calibration EWA
Rhinoanemometer (Measurement Of Nasal Decongestion) BXQ
Tester, Auditory Impedance, Exempt PTO
Media, Electroconductive GYB
Medical Device Data System OUG

Proprietary Names

Snap Electrode TM Electrode Tab Electrode Orion Nydiag 200 touchTymp REM440 MI 20 VisualEyes EyeSeeCam vHIT VisualEyes 515 2D-VOGfw VisualEyes 525 VisualEyes 505 Orion Comprehensive Basic Orion Autotraverse Basic USBM2.1 BG4 Vorteq Digital Light Bar Datalink AA222 GSI AUDIOscreener + GSI AUDIOscreener Affinity 2 Equinox Affinity Compact Affinity Callisto Sanibel REM Probe Tubes, type A Sanibel REM Probe Tubes, type D Type B probe tube AC 440 Module Probe tubes, type A Sanibel REM Probe Tubes, type C HIT 440 Module Race Car MI 22 MB 11 V0425B VN415M VO425M VN415B VO425 VF405M VNG System VN415 VF405 VF405B 2D-VOG Goggles 2D-VOG System MI 21 OtoWave EYESEECAM VHIT Aqua Stim Gold Tiptrodes Gold Eartip Electrode PILOT TEST Sanibel ETU Universal Electrode Cable, Blue Sanibel ETU Universal Electrode Cable, White Pinch clip cable Cable for TM ECochG electrode ETB Standard electrode cable kit Button electrode cable Jumper cable Alligator clip electrode cable Sanibel ETU Universal Electrode Cable, Yellow Sanibel ETU Universal Electrode Cable, Red Sanibel ETU Universal Electrode Cable, Black easyScreen OtoRead MB 11 with BERAPhone Probe VIOT Viot Suite AT235 MI 26 MI 24 GSI AudioSol GSI 61 AD226 GSI AudioStar Pro Amplivox 240 Wizard Ultra RA660 Avant ARC AC40 AS608 MA28 Amplivox 116 Amplivox 170 AM282 MA39 Amplivox 270 PA5 Amplivox 260 AD229 MA25 AC33 MA41 MA40 AD629 Welch Allyn AM282 MA1 Avant Stealth Audiometer MA42 Amplivox 160 GSI 17 GSI Pello GSI AMTAS MA27 MA52 MA33 Avant A2D+ Audiometer Detective GSI 18 GSI AMTAS Flex SMART TONE Audiometer Luna AD528 CCA-200mini Audiometer RA360 modelONE CCA-100mini Audiometer Fit Test Audiometer NEXT Audiometer Amplivox Otosure easyTone Amplivox PC850 IP30 Insert earphone Amplivox 270+ B71 Bone conductor headset DD45 Headset TDH39 Headset B-81 Bone conductor headset DD65 Headset CIR Insert earphone DD450 High frequency headset Equinox Evo DD65v2 Audiometric headset Touch Keyboard GSI AudioHub TEOAE25 GSI Allegro Welch Allyn MicroTymp 4 Otowave 202 Titan easyTymp Pro easyTymp GSI Novus ECLIPSE SYSTEMS EP25 EP15 IA OAE Suite EARturtle w/electrodes Infant EarCup w/ electrodes TM electrode for ECochG, starter kit Otoread EroScan Plus MI 34 GSI TympStar Sera GSI 70 Air Fx MI 44 Pediatric Eartip Kit EARturtle Pediatric OAE foam ear tip OAE Ear Tip Ear Tip Sanibel Jumbo OAE foam ear tip SnapPROBE(TM) Accessories Box Sanibel foam tip, small Assortment Box 1171 Sanibel foam tip, medium AOT Ear Tip Infant Ear Tip A ANA Ear Tip Infant Ear Tip B Preemie Ear Tip Ear Tip, infant MT4 Ear Tip Assortment Box BET55 ADI Ear tip sample kit Assortment Box 162 Sample bag - AuDX and OAE foam tips Sanibel foam tip, large Assortment Box Amplivox Ear Tip, flanged Assortment box 1154 Assortment Box 1161 Ear Tip, OAE-4 AuDX Ear Tip Ear Tip, OAE-3 Sanibel ADI Scre. Ear Tip kit Ear Tip, mushroom Sanibel foam tip sample kit Ear Tip, umbrella Sanibel ADI Ear Tip kit Adult OAE foam ear tip Assortment Box BET25 Ear tips 8 - 15 mm mushroom EarCup GSI Corti Welch Allyn OAE Foam ear tip, 18 mm, ER10C Foam ear tip, 10 mm, ER1/ER2 Ear tip, ER10C-06 Ear tip, ER10C-03 ER-2 Insert Earphones Ear tip, ER10C-05 Foam ear tip, 13 mm, ER10B+ Foam ear tip, 13 mm, ER10C Ear tip, ER10C-04 Foam ear tip, 10 mm, ER10C Foam ear tip, 13 mm, ER1/ER2 MT10 Lyra Audera DPOAE20 ASSR ABRIS Torque Wrench Screwdriver HexaDrive EN415 EO425 Meta-4 TRV ER-10D OAE Probe CS20 Hear Aid Calibrator System Otowave 302+ Otowave 102-C Otowave 302 Welch Allyn TM286 GSI 39 MI 23 Avant HIT+ Chamber Avant REM Sp Avant REM Speech+ AT235, AT235h RHINOSTREAM RHINOMANOMETER MODULE RHINOSCAN MODEL SRE2000/ SRE2100 GSI TympStar Pro Middle Ear Analyzer (Model: GSI TympStar Pro) OtoAccess

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device