Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Netherlands›Medis Medical Imaging Systems, Inc.

Medis Medical Imaging Systems, Inc.

Netherlands · Leiden
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class 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
2active device licences
Class II 2
5 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 States4 registration records, 18 510(k), 0 PMA, 3 excluded
Brazil2 confirmed, 3 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: MEDIS MEDICAL IMAGING SYSTEMS, B.V. · MEDIS MEDICAL IMAGING SYSTEMS B.V. · MEDIS MEDICAL IMAGING SYSTEMS BV
Same-named companies — This database also contains companies with near-identical names: MEDIS MEDICAL IMAGING SYSTEMS, B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Leiden

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

11994
31999
22000
12001
12003
42004
12005
12006
12008
12012
12015
12019

FDA listed device types

System, Image Processing, Radiological 1X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK182611Qangio XA 3D2019-05-30
USK140587MR-CT VVA2015-01-06
USK112807X-RAY VVA2012-02-27
BR80065329002QAngio XA 3DClass II
BR80065320307Medis Suite MRCTClass II
CA73773QUANTIFICATION SOFTWARE FOR US IMAGE POST-PROCESSINGClass II
CA84048QIVUS (QUANTIFICATION SOFTWARE FOR INTRAVASCULAR IMAGE POST-PROCESSING)Class II

Similar companies

Advantech Europe B.V.
Netherlands · markets 2
ASO Europe B.V.
Netherlands · markets 2
ATRO Medical BV
Netherlands · markets 0
Axxicon BV
Netherlands · markets 0
BAP Medical B.V. SKIN - SCAR - NOSE - WOUND
Netherlands · markets 1
Bondus BV
Netherlands · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →