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MAICO Diagnostics GmbH

Germany · Berlin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 9 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

12active device licences

Class II 12

36 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 7 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: MAICO Diagnostics GmbH · DIAGNOSTIC GROUP LLC DBA MAICO DIAGNOSTICS · MAICO DIAGNOSTICS GMBH · DIAGNOSTIC GROUP LLC - DBA MAICO DIAGNOSTICS

Same-named companies — This database also contains companies with near-identical names: DIAGNOSTIC GROUP LLC - DBA MAICO DIAGNOSTICS, Maico Diagnostic GmbH, Maico Diagnostics (Diagnostic Group, LLC). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22001 · K011746

12006 · K060885

12007 · K063452

12009 · K082035

12016 · K162210

12017 · K171506

FDA listed device types

Spirometer, Diagnostic 1Stimulator, Auditory, Evoked Response 1Tester, Auditory Impedance 1Audiometer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171506	Easyscreen	2017-08-29
US	K162210	touchTymp	2016-11-16
US	K082035	MAICO MB 11 WITH BERAPHONE PROBE	2009-01-29
BR	10356029047	Família de audiômetros de diagnóstico - MA	Class II
BR	10356029046	ERO SCAN	Class II
BR	10356020095	EROSCAN®	Class II
CA	61013	MA 41 AUDIOMETER	Class II
CA	61014	MA 800 AUDIOMETER	Class II
CA	61015	MA 790 AUDIOMETER	Class II

MAICO Diagnostics GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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