Manufacturer

DxTx Medical

United StatesLegal entities : DxTx Medical, Inc.

Markets : Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class II · latest in 2025 · see on the FDA website

EU representative : MedR-AR Services B.V. (Netherlands)

3 categories, 10 models including 10 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Magnetic resonance (mr) systems - hardware accessories - other	Z1105018099	1.5T Ingenia Endorectal Coil Interface Device (eCoil®) 4598-001-13802 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) 3043032 Siemens 1.5T Endo Interface (eCoil®) 7582385 Siemens 3.0T Endo Interface (eCoil®) 8624855 Siemens 3.0T Endo Interface II with Tim 4G Slide Connect (e2CoilTM) 4000518	I MDR	EUDAMED record Report an error
Magnetic resonance (mr) radiofrequency volumetric coils	Z1105018002	3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) BPX 1593/42 Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®) BPX 3093/42 Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens BPX 30 NG-S	I, IIa MDR, 93/42	EUDAMED record Report an error
Radiotherapy treatment planning instruments - consumables	Z11010485	Pro-Tx Endorectal Balloon PROT-25	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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