Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043520099

FEI Number

3043520099

Entity Name

BACHGOLD AG

City/State/Country

Zurich, CH

Establishment Address

Freyastrasse 11, Zurich 8004, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bachgold AG (Owner Number: 10095158)

Owner / Operator Contact Address

Freyastrasse 11, Zürich, CH-NOTA 8004, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing Aid, Over the Counter Hearing Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2026-01-29

Official Correspondent

Laurenz Elbers

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Bachgold AG

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 3043520099. Last updated year: 2026. Please use registration number 3043520099 when referencing this establishment in official correspondence.