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Home›Israel›Meridian Bioscience Israel , Ltd.

Meridian Bioscience Israel , Ltd.

Israel · Modiin
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
53listed device types
Class I 29Class II 23Class III 0unclassified 1
plus 92 registration records and 41 510(k), 15 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 3Class II 7
24 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
49active device licences
Class II 20Class III 29
91 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States92 registration records, 41 510(k), 15 PMA, 15 excluded
Brazil10 confirmed, 2 excluded
Canada49 confirmed, 3 excluded
Manufacturer names merged into this page: MERIDIAN BIOSCIENCE, INC. · Meridian Bioscience Canada Inc. · Meridian Bioscience Israel Ltd. · MERIDIAN BIOSCIENCE ISRAEL LTD. · MERIDIAN BIOSCIENCE · MERIDIAN BIOSCIENCE, INC
Same-named companies — This database also contains companies with near-identical names: MERIDIAN BIOSCIENCE, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Israel
City
Modiin

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 510(k) clearances by year

22003
22004
12005
12006
32007
32009
12010
42011
32012
12013
22014
32015
22016
12017
22018
12020
12021
42022
32023
12025

FDA listed device types

showing 8 of 53
Antigen, Elisa, Cryptococcus 1Enzyme Linked Immunosorbent Assay, Coccidioides Immitis 1Antiserum, Positive Control, Histoplasma Capsulatum 1Antigen, Latex Agglutination, Coccidioides Immitis 1Bordetella Pertussis Dna Assay System 1Antigen, Cf And / Or Id, Coccidioides Immitis 1Devices Detecting Influenza A, B, And C Virus Antigens 1System, Test, Infectious Mononucleosis 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243922Revogene2025-03-20
USK230901Premier HpSA Flex (619096)2023-07-03
USK222829Curian® Shiga Toxin2023-04-17
BR10230730055PREMIER ROTACLONE ROTAVIRUSClass II
BR10230730034MERIFLUOR CRYPTOSPORIDIUM/GIARDIAClass II
BR10230730050MERIFLUOR PNEUMOCISTISClass II
CA1694PARA-PAK SPINCON CONCENTRATION SYSTEMClass II
CA4296VZV IGM TEST KITClass III
CA5884VZV IGG TEST KITClass III

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