Manufacturer

Agfa

BelgiumLegal entities : Agfa NV

Markets : Belgium · France · Germany · Poland · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 29 · class I, II · latest in 2021 · see on the FDA website

Public contracts won : Spain 8 · Poland 7 · France 4 · Belgium 1

Website

11 categories, 40 models including 40 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Digital computed radiography (cr) systems - hardware accessories	Z11060280	CR HD5.0 FLFS CASSETTE CR: HD5.0, HM5.0, MD4.0R(cassettes)3 refs CR MD1.0 CASSETTE ADAPTER CR MD1.0 GENERAL SET CR MD1.0 Set3 refs CR MD4.0 GENERAL SET CR Set Mx.093/42 CR MD4.0 GENERAL SET HR CR Set Mx.093/42 8 others CR MD4.0 GENERAL SET SR CR Set Mx.093/42 CR MD4.0R FLFS SET CR: HD5.0, HM5.0, MD4.0R93/42 CR MD4.0R GENERAL (SR) SET CR: HD5.0, HM5.0, MD4.0R4 refs93/42 CR MD4.0T FLFS SET CR Set Mx.0T93/42 CR MD4.0T GENERAL SET CR Set Mx.0T5 refs93/42 CR MM3.0 MAMMO SET CR Set Mx.02 refs93/42 CR MM3.0T MAMMO SET CR Set Mx.0T2 refs93/42 ID-tablet	I, IIa MDR, 93/42	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	DR 100e 60122 refs DR 100s 6013 DR 400 55203 refs DR 600 5530 DR Retrofit 5400 3 others DX-D 300 8207 HarmonX 5600 Valory 5540	IIb MDR	EUDAMED record Report an error
Systems for direct digital radiology (dr) - hardware accessories	Z11031180	DR 18M 540093/42 DR 24M 540093/42 DR 600 FLFS Horizontal Overlay3 refs DR Generator Sync Box DR Retrofit 5400 EASYLIFT2 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Single-input computed radiography (cr) systems	Z11060201	CR 10-X Digitizer 515193/42 CR 12-X Digitizer 515193/42 CR 15-X Digitizer 515193/42	IIa 93/42	EUDAMED record Report an error
Video or digital bioimaging players	Z110706	Crystal Imager Printer 53663 refs Crystal-M Imager Printer 53672 refs Drystar 5503 Printer 5364	I MDR	EUDAMED record Report an error
Column stands for radiological equipment	Z11030501	DR FLFS Detector Positioner2 refs WS-Manual-001 DR Wallstand 55203 refs	I MDR	EUDAMED record Report an error
General purpose X-ray films	Z130101	CP-BU M8 refs93/42 Ortho CP-GU M10 refs93/42	IIa 93/42	EUDAMED record Report an error
Digital remote control tables	Z11030702	DR 800 6010	IIb MDR	EUDAMED record Report an error
Dry thermal printer X-ray films	Z130106	CAWO DRY FILM3 refs	I MDR	EUDAMED record Report an error
Remote control tables - software accessories	Z11030782	NX 3.02 refs	IIb MDR	EUDAMED record Report an error
Various X-ray film imaging support instruments - consumables	Z11079085	E.O.S. DEV.3 refs	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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