HomeNorwayMEDISTIM ASA

MEDISTIM ASA

Norway · Oslo
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
6listed device types
Class I 0Class II 6Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
4 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
Class III 3IIa 2IIb 2
HKHong KongMDACS
2valid listings
Class IV 2
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 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 States6 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: MEDISTIM ASA

Company information

Country
Norway
City
Oslo

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 listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Probe, Blood-Flow, Extravascular 1Flowmeter, Blood, Cardiovascular 1System, Imaging, Pulsed Doppler, Ultrasonic 1Computer, Blood-Pressure 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80190320017VASCULAR PROBES AUTOCLAVABLE STEAM BATHClass I
BR80190320018QUICKFIT PROBESClass I
CA72450VERIQ SYSTEMClass III

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