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
- [email protected]
- Phone
- 952 9476097
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2011-11-11 |
| Apparatus, Vestibular Analysis | LXV | Class U | Unknown | No | 2011-03-07 |
| Tester, Auditory Impedance | ETY | Class 2 | Ear, Nose, Throat | No | 2016-11-21 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2026-03-25 |
| Calibrator, Hearing Aid / Earphone And Analysis Systems | ETW | Class 2 | Ear, Nose, Throat | No | 2014-03-13 |
| Nystagmograph | GWN | Class 2 | Neurology | No | 2020-11-06 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2013-01-11 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2020-04-28 |
| Stimulator, Caloric-Water | ETP | Class 1 | Ear, Nose, Throat | No | 2013-08-22 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2026-03-25 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2013-01-14 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2026-03-25 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2011-03-24 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2026-03-25 |
| Tympanometer, Exempt | PTP | Class 2 | Ear, Nose, Throat | No | 2018-06-26 |
| Tympanometer | NAS | Class 2 | Ear, Nose, Throat | No | 2021-12-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2026-03-25 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-08-05 |
| Stimulator, Caloric-Air | KHH | Class 1 | Ear, Nose, Throat | No | 2013-08-22 |
| Cushion, Earphone (For Audiometric Testing) | ETT | Class 1 | Ear, Nose, Throat | No | 2021-07-22 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2020-11-02 |
| Set, Audiometer Calibration | EWA | Class 1 | Ear, Nose, Throat | No | 2007-04-02 |
| Rhinoanemometer (Measurement Of Nasal Decongestion) | BXQ | Class 2 | Anesthesiology | No | 2004-01-28 |
| Tester, Auditory Impedance, Exempt | PTO | Class 2 | Ear, Nose, Throat | No | 2017-07-14 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2025-08-19 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-04-19 |
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