HomeBelgiumAgfa Corporation

Agfa Corporation

Belgium · Greenville
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Hong Kong, Russia — 5 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
23510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 23 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class I 6Class II 8
20 including historic records
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
9active ARTG entries
Class I 3IIa 2IIb 4
HKHong KongMDACS
5valid listings
Class III 5
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2a 2Class 2b 2
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, 23 510(k), 0 PMA, 16 excluded
Brazil14 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: AGFA NV

Company information

Country
Belgium
City
Greenville

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

12000
42001
52002
12003
42004
42005
42006

Registration details (sample)

MarketIdentifierNameClass / date
USK063421DX-SI2006-11-22
USK062742CR 85-X2006-10-13
USK062223AGFA MODEL CR30-X2006-09-01
BR80497200026Detector para sistema de radiografia digitalClass II
BR80497200009IMPRESSORA DRYSTARClass I
BR80497200008PROCESSADORAS PARA REVELACAO DE FILMESClass I

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