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Home›Finland›Orion Diagnostica, Div. Orion Corp.

Orion Diagnostica, Div. Orion Corp.

Finland · Espoo
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
36510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 36 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
11active device licences
Class II 11
20 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 States0 registration records, 36 510(k), 0 PMA, 10 excluded
Canada11 confirmed, 2 excluded
Manufacturer names merged into this page: ORION DIAGNOSTICA OY
Same-named companies — This database also contains companies with near-identical names: Orion Diagnostica, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Finland
City
Espoo

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

111980
21981
11982
11983
11984
11985
21986
21987
41988
11991
11992
11994
11995
11997
12002
12003
22004
12005
12016

Registration details (sample)

MarketIdentifierNameClass / date
USK142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument2016-03-10
USK043125ORION DIAGNOSTICA UNIQ PINP RIA2005-05-04
USK042625QUIKREAD CRP CALIBRATOR SET2004-11-18
CA2706PICP RIAClass II
CA2707P III NP RIAClass II
CA6369SHBG IRMAClass II

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