Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011925220

FEI Number

3011925220

Entity Name

CASTLE HEARING LIMITED

City/State/Country

Dumfries Dumfries and Galloway, GB

Establishment Address

Browne House, Crichton Business Park, Dumfries Dumfries and Galloway DG1 4ZZ, GB

Establishment Type(s)

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

Owner / Operator

Castle Hearing Limited (Owner Number: 10052195)

Owner / Operator Contact Address

Browne House, Crichton Business Park, Dumfries, GB-DGY DG1 4ZZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Widex Nanocare Phonak Cerustop Cerustop Wax Guards WIDEX DOMES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2016-06-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Castle Hearing Limited

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 3011925220. Last updated year: 2026. Please use registration number 3011925220 when referencing this establishment in official correspondence.