FDA Registration Active 🇵🇱 Poland

Sample bag - AuDX and OAE foam tips

Reg #: 3011310592 · FEI: 3011310592 · Expires 2025
Products
1
Proprietary Names
38
Establishment Types
1
Classifications
1

Registration Details

Registration Name
DGS Diagnostics Sp. z o.o
Registration Number
3011310592
FEI Number
3011310592
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Rosowek 43
City
Kolbaskowo Zachodniopomorskie
Country
PL

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
Cushion, Earphone (For Audiometric Testing) ETT

Proprietary Names

Sample bag - AuDX and OAE foam tips EARturtle Ear Tip, flanged Sanibel foam tip, large Ear Tip, infant Assortment Box Amplivox SnapPROBE(TM) Accessories Box AuDX Ear Tip Sanibel foam tip sample kit Assortment Box 1161 Sanibel foam tip, medium Assortment Box BET25 Sanibel ADI Ear Tip kit Assortment Box 1171 AOT Ear Tip ADI Ear tip sample kit Infant Ear Tip B Preemie Ear Tip Sanibel foam tip, small MT4 Ear Tip Ear Tip Ear Tip, umbrella Assortment Box BET55 Sanibel Jumbo OAE foam ear tip EarCup Assortment Box 162 Assortment box 1154 ANA Ear Tip Adult OAE foam ear tip Infant Ear Tip A Pediatric OAE foam ear tip OAE Ear Tip Ear Tip, OAE-3 Ear tips 8 - 15 mm mushroom Sanibel ADI Scre. Ear Tip kit Ear Tip, mushroom Ear Tip, OAE-4 Pediatric Eartip Kit

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)