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Home›Sweden›Scandidos AB

Scandidos AB

Sweden · Uppsala
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 4 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(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
1active device licences
Class II 1
5 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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, 5 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: SCANDIDOS AB

Company information

Country
Sweden
City
Uppsala

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

12006 · K052920
12015 · K151180
12016 · K151426
12019 · K183606
12024 · K223234

Registration details (sample)

MarketIdentifierNameClass / date
USK223234Delta4 Insight2024-01-16
USK183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)2019-04-08
USK151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+2016-01-29
CA90959DELTA 4PTClass II

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