Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032874372

FEI Number

3032874372

Entity Name

AUDELATION

City/State/Country

London London, City of, GB

Establishment Address

Suite 63, 61 Praed Street, London London, City of w2 1NS, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Audelation (Owner Number: 10091390)

Owner / Operator Contact Address

Suite 63, 61 Praed Street, London, GB-LND w2 1NS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OWL OWL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2024-10-13
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2024-10-13

Official Correspondent

Tsong Kwong

US Agent Details

David Kemp Business: Oaktree Products Email: DKemp@oaktreeproducts.com Phone: (636) 5301664

Related Public Records

Same Entity

Audelation

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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

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3030410270	Deebo Warehouse	Raleigh, NC, US
3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL
9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032874372. Last updated year: 2026. Please use registration number 3032874372 when referencing this establishment in official correspondence.