Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005019184

FEI Number

3005019184

Entity Name

Sivantos GmbH

City/State/Country

Erlangen Bavaria, DE

Establishment Address

Henri-Dunant-Str. 100, Erlangen Bavaria 91058, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

WSAUD A/S (Owner Number: 10023518)

Owner / Operator Contact Address

Nymoellevej 6, Lynge, DK-84 DK, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233464

PMA Number

N/A

All Registered Proprietary Names

CROS Motion Charge&Go Intuis Insio Charge&Go CROS AX Signia Pure Insio Insio IX Active Pro IX Intuis 3 Intuis 4 Silk Charge&Go Signia Motion Styletto AX Styletto Pure Charge&Go Unity 3 hearing instrument Unity 3 Unity 2 Unity 2 probe Miracle-Ear Pure Charge&Go AX Intuis 4 Styletto IX Intuis 3 Active Pro IX Pure Charge&Go IX CROS Motion Nx Rexton BiCore Signia AX Signia Intuis Signia X Rexton M-Core Signia IX Signia Insio Rexton Rexton Reach Signia Active Pro Signia Active Insio Charge&Go Styletto SmartRIC Insio Nx Silk Charge&Go IX Connexx Motion Charge&Go IX CROS X CROS AX Insio IX Motion X Styletto AX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2010-01-29
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2010-04-12
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2010-03-23
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-08-24
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2011-07-12
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2024-05-01
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2024-05-01

Official Correspondent

Isabel Restivo

US Agent Details

Isabel Restivo Business: WS Audiology USA, Inc. Email: isabel.restivo@wsa.com Phone: (551) 5799581

Related Public Records

Same Entity

WSAUD A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

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3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005019184. Last updated year: 2026. Please use registration number 3005019184 when referencing this establishment in official correspondence.