HomeGermanyMerck KGaA

Merck KGaA

Germany · Darmstadt
✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000018777

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel, Russia — 8 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
167UDI-DI device records
IVD A 159IVD B 8
USUnited StatesFDA openFDA
70listed device types
Class I 70Class II 0Class III 0
plus 70 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
16registered device records
IVD general 16
BRBrazilANVISA
6registered devices
Class I 6
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
0active device licences
TWTaiwanTFDA
16valid device licences
Class I 16
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IVD Class 1 2IVD Class 2 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 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.

European Union289 raw hits, 122 excluded, 167 confirmed
United States70 registration records, 0 510(k), 0 PMA, 7 excluded
United Kingdom16 confirmed, 2 excluded
Brazil6 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: MERCK KGAA

Regulatory identity

EU manufacturer SRN
DE-MF-000018777
UK responsible person
Millipore (UK) Ltd

Company information

Country
Germany
City
Darmstadt
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulation

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
Merck Holding GmbH
LEI
5299006GCDR2RF73EZ08
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1999-02-02
Registration authority
Commercial Register, no. HRB 7293
Registry record updated
2025-09-11

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 70
Iron Stains 1Stains, Microbiologic 1Malachite Green 1Trypan Blue 1Toluidine Blue 1Antigens, All Types, Escherichia Coli 1Resorcin Fuchsin 1Thionin 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04022536023649Canada balsam for microscopyIVD A
EU04022536111940Giemsa’s azur eosin methylene blue solution for microscopyIVD B
EU04022536111926Giemsa’s azur eosin methylene blue solution for microscopyIVD B
EU04022536707389Giemsa’s azur eosin methylene blue solution for microscopyIVD B
UK57753Formaldehyde solution min. 37% free from acid IVD general
UK43510ISOSLIDE EVGIVD general
UK43587ACRIDINE ORANGE ZINC CHLORIDE DOUBLE SALT (C.I.46005) FOR MICROSCOPY CERTISTAINIVD general
BR81167700002Família Corantes HematopatológicosClass I
BR81167700003Família Corantes MicrobiológicosClass I
BR80141300390Corantes Hematopatológicos MerckClass I

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