HomeSwitzerlandMEDION GRIFOLS DIAGNOSTICS AG

MEDION GRIFOLS DIAGNOSTICS AG

Switzerland · Dudingen
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, 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
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 3Class II 1
42 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
14device registrations
CLASS B 1CLASS C 7CLASS D 6
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
8active ARTG entries
IVD Class 2 1IVD Class 3 5IVD Class 4 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States3 registration records, 0 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: MEDION GRIFOLS DIAGNOSTICS AG · MEDION DIAGNOSTICS GRIFOLS AG
Same-named companies — This database also contains companies with near-identical names: MEDION DIAGNOSTICS GRIFOLS AG. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Switzerland
City
Dudingen

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.

FDA listed device types

System, Test, Combs, Automated 1Kit, Quality Control For Blood Banking Reagents 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80134860260Bromelase® 30Class I
BR80134860286Specific Albumin 22%Class I
BR80134860287Enlisst-IIClass I

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