Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002504821

FEI Number

3002504821

Entity Name

MAICO Diagnostics GmbH

City/State/Country

Berlin, DE

Establishment Address

Sickingenstr. 70-71, Berlin 10553, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

DEMANT A/S (Owner Number: 8010048)

Owner / Operator Contact Address

KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011746

PMA Number

N/A

All Registered Proprietary Names

Titan easyTymp Pro easyTymp touchTymp GSI AudioSol GSI 61 AD226 GSI AudioStar Pro Amplivox 240 Wizard Ultra RA660 Avant ARC AC40 AS608 MA28 Amplivox 116 Amplivox 170 AM282 MA39 Amplivox 270 PA5 Amplivox 260 AD229 MA25 AC33 MA41 MA40 AD629 Welch Allyn AM282 MA1 Avant Stealth Audiometer MA42 Amplivox 160 GSI 17 GSI Pello GSI AMTAS MA27 MA52 MA33 Avant A2D+ Audiometer Detective GSI 18 GSI AMTAS Flex SMART TONE Audiometer Luna AD528 CCA-200mini Audiometer RA360 modelONE CCA-100mini Audiometer Fit Test Audiometer NEXT Audiometer Amplivox Otosure easyTone Amplivox PC850 IP30 Insert earphone Amplivox 270+ B71 Bone conductor headset DD45 Headset TDH39 Headset B-81 Bone conductor headset DD65 Headset CIR Insert earphone DD450 High frequency headset Equinox Evo DD65v2 Audiometric headset Touch Keyboard GSI AudioHub Otoread EroScan Plus easyScreen MB 11

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	2011-11-11
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2016-11-21
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	1994-09-21
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-10-24
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-08-30
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2017-08-30
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Brandon Bell Email: bnbl@grason-stadler.com Phone: (952) 9476097

Related Public Records

Same Entity

DEMANT A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032579106	ITSA Medical	Vallauris Alpes-Maritimes, FR
3017441596	Demant Operations, S.a. De C.v.	Tijuana Baja California, MX
2240713	OTICON, INC.	SOMERSET, NJ, US
3005465494	Oticon A/S	Smorum Hovedstaden, DK
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

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 3002504821. Last updated year: 2026. Please use registration number 3002504821 when referencing this establishment in official correspondence.