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MIKROGEN GmbH

www.mikrogen.de

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United Kingdom, Canada, Singapore, Russia — 4 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

0UDI-DI device records

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

37registered device records

IVD general 29IVD Annex II List B 8

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

13 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

6device registrations

CLASS C 4CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 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 Kingdom37 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: MIKROGEN GMBH

Regulatory identity

UK responsible person: IVDeology UKRP Ltd
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
UK	51006	Helicobacter pylori IgA positive control	IVD general
UK	51010	Helicobacter pylori IgG positive control	IVD general
UK	42021	HEV IgG positive control	IVD general
CA	84665	RECOMBLOT BORRELIA NB IGG	Class II
CA	84672	RECOMBLOT BORRELIA NB IGM	Class II

MIKROGEN GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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