HomeGermanyInstitut VirionSerion GmbH

Institut VirionSerion GmbH

Germany · Würzburg
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, 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
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
0registered device records
BRBrazilANVISA
27registered devices
Class I 3Class II 24
58 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
37 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 1CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
14active ARTG entries
IVD Class 1 1IVD Class 2 3IVD Class 3 10
HKHong KongMDACS
2valid listings
IVD B 1IVD C 1
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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.

Brazil27 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: INSTITUT VIRION/SERION GMBH · INSTITUT VIRION\SERION GMBH · INSTITUT VIRION SERION GMBH · Institut Virion/ Serion GmbH

Company information

Country
Germany
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsMicrobiology & infectious disease diagnostics

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR81905510080SERION RF AbsorbentClass II
BR81905510065SERION ELISA classic Herpes Simplex Virus 1 IgMClass II
BR81905510072SERION ELISA classic Herpes Simplex Virus 1 IgGClass II
SAME0000011906SFDAA00255Serion Clean

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