FDA Registration Active 🇩🇰 Denmark

INTERACOUSTICS A/S

Reg #: 9710051 · FEI: 3000254565 · Expires 2026
Products
16
Proprietary Names
215
Establishment Types
6
Classifications
16

Registration Details

Registration Name
INTERACOUSTICS A/S
Registration Number
9710051
FEI Number
3000254565
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Audiometer Alle 1
City
Middelfart Syddanmark
Country
DK

Regulatory Submissions

510(k) Number
K994254

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
Tester, Auditory Impedance ETY
Audiometer EWO
Nystagmograph GWN
Cable, Electrode IKD
Stimulator, Auditory, Evoked Response GWJ
Electrode, Cutaneous GXY
Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
Stimulator, Caloric-Water ETP
Apparatus, Vestibular Analysis LXV
Tester, Auditory Impedance, Exempt PTO
Medical Device Data System OUG
Rhinoanemometer (Measurement Of Nasal Decongestion) BXQ
Otoscope ERA
Stimulator, Caloric-Air KHH
Cushion, Earphone (For Audiometric Testing) ETT
Set, Audiometer Calibration EWA

Proprietary Names

AT235, AT235h Lyra 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 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 GSI TympStar Sera MT10 Gold Tiptrodes Gold Eartip Electrode V0425B VN415M VO425M VN415B VO425 VF405M VNG System VN415 VF405 VF405B 2D-VOG Goggles 2D-VOG System DPOAE20 IA OAE Suite ECLIPSE SYSTEMS EP25 EP15 EARturtle w/electrodes Infant EarCup w/ electrodes TM electrode for ECochG, starter kit Hear Aid Calibrator System Aqua Stim Welch Allyn TM286 GSI 39 AA222 Orion Nydiag 200 easyTymp TRV Audera TEOAE25 OtoAccess REM440 GSI AUDIOscreener + GSI AUDIOscreener RHINOSTREAM RHINOMANOMETER MODULE RHINOSCAN MODEL SRE2000/ SRE2100 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 EN415 EO425 Meta-4 VIOT Viot Suite OtoRead Air Fx MB 11 with BERAPhone Probe AT235 EYESEECAM VHIT Otoread EroScan Plus ER-10D OAE Probe 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 Snap Electrode TM Electrode Tab Electrode 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 CS20 GSI 70 ASSR ABRIS Titan easyTymp Pro 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 MB 11

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device