HomeSwedenARCOMA AB

ARCOMA AB

Sweden · Vaxjo
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Russia — 6 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 2Class II 4Class III 0
plus 6 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
2active device licences
Class II 2
5 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 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, 2 510(k), 0 PMA
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: ARCOMA AB

Company information

Country
Sweden
City
Vaxjo

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

12008 · K073632
12014 · K140683

FDA listed device types

Holder, Radiographic Cassette, Wall-Mounted 1Tube Mount, X-Ray, Diagnostic 1Table, Radiographic, Tilting 1System, X-Ray, Stationary 1Table, Radiographic, Non-Tilting, Powered 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK1406830180 INTUITION, 0072 PRECISION2014-06-03
USK073632INTUITION, MODEL 01702008-01-10
CA76930IMIX 2000 DETECTORClass II
CA85816PANORAD DIGITAL X-RAY SYSTEMClass II

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