Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012593436

FEI Number

3012593436

Entity Name

ING. GERHARD FILDAN GMBH

City/State/Country

Ebenfurth Niederosterreich, AT

Establishment Address

Ing. Gerhard Fildan Strasse 1, Ebenfurth Niederosterreich 2490, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ing. Gerhard Fildan GmbH (Owner Number: 10092154)

Owner / Operator Contact Address

Ing. Gerhard Fildan Strasse 1, Ebenfurth, AT-3 2490, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Baha Softband

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2024-12-10

Official Correspondent

Gerhard Fildan

US Agent Details

Alan Edo Business: Fildan Accessories Email: aedo.fildan@gmail.com Phone: (203) 9095052

Related Public Records

Same Entity

Ing. Gerhard Fildan GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012593436. Last updated year: 2026. Please use registration number 3012593436 when referencing this establishment in official correspondence.