HomeFinlandIcare Finland Oy

Icare Finland Oy

Finland · Vantaa
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 4 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 2Class II 2
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
4active device licences
Class II 4
12 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 3IIa 4
HKHong KongMDACS
4valid listings
Class II 4
ILIsraelAMAR
9registrations
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.

United States4 registration records, 7 510(k), 0 PMA, 5 excluded
Brazil4 confirmed, 1 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: Icare Finland Oy · ICARE FINLAND OY · ICARE FINLAND OY/TIOLAT OY

Company information

Country
Finland
City
Vantaa

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

12016 · K153694
12017 · K163343
22020 · K200966
22022 · K220852
12024 · K241447

FDA listed device types

Tonometer, Ac-Powered 1Tonometer, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241447iCare ST500 (TA04)2024-09-27
USK220852iCare IC2002022-10-06
USK211355iCare HOME22022-01-25
BR81504790001TONÔMETRO ICAREClass II
BR81504790102Probe Icare TP01Class II
BR81504790104Icare clinicClass I
CA83505ICARE ONE TONOMETER PROBEClass II
CA83507ICARE ONE TONOMETERClass II
CA86675ICARE PRO TONOMETERClass II

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