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Aesku.Diagnostics GmbH & Co. KG

Germany · Wendelsheim

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

16listed device types

Class I 4Class II 12Class III 0

plus 20 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

34registered devices

Class I 1Class II 33

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

33active device licences

Class II 33

71 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IVD Class 2 1

HKHong KongMDACS

3valid listings

IVD B 1IVD C 2

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 10Class 2b 1

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 States20 registration records, 11 510(k), 0 PMA, 2 excluded

Brazil34 confirmed, 0 excluded

Canada33 confirmed, 0 excluded

Manufacturer names merged into this page: AESKU.DIAGNOSTICS GmbH&Co.KG · AESKU.DIAGNOSTICS GMBH & CO. KG · AESKU DIAGNOSTICS GMBH & CO. KG · AESKU DIAGNOSTICS

FDA 510(k) clearances by year

22004

12006

22008

22010

12012

12013

22018

FDA listed device types

showing 8 of 16

Station, Pipetting And Diluting, For Clinical Use 1Calculator/Data Processing Module, For Clinical Use 1Light, Microscope 1Multi-Analyte Controls Unassayed 1Antinuclear Antibody, Antigen, Control 1System, Test, Anticardiolipin Immunological 1Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 1Autoantibodies, Endomysial(Tissue Transglutaminase) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172461	AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin	2018-03-23
US	K172348	AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10	2018-02-16
US	K132082	AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK	2013-12-05
BR	82910510001	AESKUSLIDES rLKS	Class II
BR	82910510002	AESKUSLIDES ANA HEp-2	Class II
BR	82910510003	AESKUSLIDES ANCA Ethanol	Class II
CA	76813	AESKULISA ENA-6PRO	Class II
CA	77282	AESKULISA TTG-G	Class II
CA	77283	AESKULISA TTG-A	Class II

Aesku.Diagnostics GmbH & Co. KG

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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