Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006285900

FEI Number

3006285900

Entity Name

ASICOMO A/S

City/State/Country

Rodby Sjalland, DK

Establishment Address

Finlandsvej 8, Rodby Sjalland 4970, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Asicomo A/S (Owner Number: 10086286)

Owner / Operator Contact Address

Finlandsvej 8, Rodby, DK-85 4970, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033645

PMA Number

N/A

All Registered Proprietary Names

Silicone Eartip, 5mm, blue, tree tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2025-11-25

Official Correspondent

Jorgen Rasmussen

US Agent Details

Danda Zhao Email: danda.zhao@natus.com Phone: (630) 7201134

Related Public Records

Same Entity

Asicomo 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
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08

Similar Registrations

Registration Number	Establishment Name	Location
9710051	INTERACOUSTICS A/S	Middelfart Syddanmark, DK
3011310592	DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, PL
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3003138182	AMPLIVOX LTD	Birmingham, GB
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006285900. Last updated year: 2026. Please use registration number 3006285900 when referencing this establishment in official correspondence.