Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Iceland›Kvikna Ehf

Kvikna Ehf

Iceland · Reykjavik
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 1 registration records and 2 510(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
0active device licences
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 States1 registration records, 2 510(k), 0 PMA
Manufacturer names merged into this page: Kvikna Medical ehf
Same-named companies — This database also contains companies with near-identical names: Kvikna Medical ehf. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Iceland
City
Reykjavik

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

12013 · K123665
12015 · K143487

FDA listed device types

Full-Montage Standard Electroencephalograph 1Non-Normalizing Quantitative Electroencephalograph Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK143487Lifelines iEEG2015-08-21
USK123665LIFELINES IEEG2013-03-25

Similar companies

KERECIS EHF
Iceland · markets 1
KISO EHF
Iceland · markets 1
Kvikna Medical ehf
Iceland · markets 2
Medcare Flaga
Iceland · markets 1
NECKCARE
Iceland · markets 1
NOX MEDICAL
Iceland · markets 8
Is this your company? Claim the page, add information or report a data error.Claim / report an error →