HomeBelgiumAGFA N.V.

AGFA N.V.

Belgium · Mortsel
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Israel, 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
13listed device types
Class I 4Class II 9Class III 0
plus 36 registration records and 6 510(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
19active device licences
Class II 16Class III 3
35 including historic records
TWTaiwanTFDA
5valid device licences
Class I 3Class II 2
SGSingaporeHSA SMDR
4device registrations
CLASS B 3CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
30active registrations
Class 2a 11Class 2b 19
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 States36 registration records, 6 510(k), 0 PMA, 16 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada19 confirmed, 3 excluded
Manufacturer names merged into this page: AGFA N.V.

Company information

Country
Belgium
City
Mortsel

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

22019 · K191884
12020 · K193262
32021 · K213469

FDA listed device types

showing 8 of 13
System, Image Processing, Radiological 1Camera, Multi Format, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1System, X-Ray, Tomographic 1Radiology-Diagnostic Kit 1Full Field Digital, System, X-Ray, Mammographic 1System, X-Ray, Stationary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213469VALORY2021-11-18
USK212145DR 800 with DSA, DR 8002021-08-31
USK211790DX-D Imaging Package with XD Detectors2021-07-30
CA30295DIGITAL ID CAMERASClass II
CA69142DX-S DIGITIZERClass II
CA71739CR 85-X DIGITIZERClass III

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