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DE GÖTZEN SRL

Last updated May 27, 2026

What DE GÖTZEN SRL makes

DE Götzen SRL manufactures digital dental X-ray systems, including stationary intraoral and panoramic/tomographic units, as well as mobile intraoral devices. Their portfolio also includes intraoral digital imaging sensors and software applications for panoramic/tomographic imaging. These products are designed for intraoral and panoramic dental radiography, enabling high-resolution imaging for diagnostic purposes.

The company’s devices are classified under Class II in the FDA’s regulatory framework and are listed in the FDA’s Unique Device Identifier (UDI) database. DE Götzen SRL operates from the United States, adhering to applicable U.S. medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does DE Götzen SRL manufacture?

DE Götzen SRL specializes in digital dental X-ray systems. Their product range includes stationary intraoral and panoramic/tomographic X-ray machines, mobile intraoral X-ray units, intraoral digital imaging sensors, and software applications for panoramic/tomographic imaging. These devices are designed to provide high-resolution imaging for dental diagnostics.

Where is DE Götzen SRL based?

DE Götzen SRL is based in the United States. The company develops and manufactures its devices while adhering to U.S. medical device regulations.

Which regulatory registries list DE Götzen SRL’s devices?

DE Götzen SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.

How are DE Götzen SRL’s devices classified under U.S. regulations?

DE Götzen SRL’s devices fall under Class II classification in the FDA’s regulatory framework. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, as they pose moderate risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: acteongroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +390331376760
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 433051802

Catalogue (96)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
X-MIND prime	XMP 2D CEPH 110-240V	FDA UDI	Class II	Active
X-MIND optima 3D	XMO 3D WALL 100-240V + WS + MONITOR	FDA UDI	Class II	Active
X-MIND prime	XMP 2D CEPH DOUBLE SENSOR 110-240V	FDA UDI	Class II	Active
X-MIND unity	XMU NO BRACKET SHORT CONE	FDA UDI	Class II	Active
X-MIND unity	XMU BOTTOM 80 SHORT CONE	FDA UDI	Class II	Active
X-MIND unity	XMU BOTTOM 110 SHORT CONE	FDA UDI	Class II	Active
Acteon Imaging Suite	ACTEON IMAGING SUITE	FDA UDI	Class II	Active
xgenus Vega	XG VEGA SIZE 1	FDA UDI	Class II	Active
X-MIND unity	XMU BOTTOM 110 LONG CONE	FDA UDI	Class II	Active
X-MIND optima	XMO 2D FLOOR 100-240V	FDA UDI	Class II	Active
xgenus Vega HD	XG VEGA HD SIZE 2	FDA UDI	Class II	Active
X-MIND trium	XMT PAN L CEPH R	FDA UDI	Class II	Unknown
X-MIND trium	XMT PAN R	FDA UDI	Class II	Unknown
X-MIND unity	XMU TOP 110 LONG SQUARE CONE	FDA UDI	Class II	Active
X-MIND trium	XMT PAN 3D L CEPH READY R	FDA UDI	Class II	Unknown
X-MIND unity	XMU TOP 80 LONG SQUARE CONE	FDA UDI	Class II	Active
X-MIND trium	XMT PAN 3D R CEPH L	FDA UDI	Class II	Unknown
X-MIND optima	XMO 2D CEPH 100-240V	FDA UDI	Class II	Active
X-MIND prime	XMP 2D FLOOR 100-240V	FDA UDI	Class II	Active
X-MIND trium	XMT PAN 3D R CEPH READY L (PAN SENSOR)	FDA UDI	Class II	Unknown
X-MIND trium	XMT PAN L	FDA UDI	Class II	Unknown
X-MIND unity	XMU TOP 40 SHORT CONE	FDA UDI	Class II	Active
X-MIND unity	XMU BOTTOM 80 LONG SQUARE CON	FDA UDI	Class II	Active
xgenus Vega HD	XG VEGA HD SIZE 1	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V VET,SHORT CONE,BOTT 40 (16” - 40,64cm)	FDA UDI	Class II	Active
U-Sense	U-SENSE SIZE 1	FDA UDI	Class II	Active
Acteon Imaging Suite	ACTEON IMAGING SUITE (DVD):	FDA UDI	Class II	Active
X-MIND unity	XMU TOP 80 LONG CONE	FDA UDI	Class II	Active
X-MIND prime 3D	XMP 3D COLUMN 110-240V + WS + MONITOR	FDA UDI	Class II	Active
X-MIND trium	XMT PAN L CEPH READY R	FDA UDI	Class II	Unknown
x-mind dc	DC X-MIND 115V,SHORT CONE,TOP 110 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND unity	XMU TOP 110 LONG CONE	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V VET,SHORT CONE,TOP 40 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND unity	XMU CORE KIT VET SC NO BRACKET	FDA UDI	Class II	Active
X-MIND optima 3D	XMO 3D CEPH 100-240V NO WS NO MONITOR	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V VET,SHORT CONE,TOP 110 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND trium	XMT PAN 3D READY L	FDA UDI	Class II	Unknown
X-MIND optima	XMO 2D CEPH DOUBLE SENSOR 100-240V	FDA UDI	Class II	Active
X-MIND unity	XMU BOTTOM 40 SHORT CONE	FDA UDI	Class II	Active
X-MIND optima 3D	XMO 3D WALL 100-240V NO WS NO MONITOR	FDA UDI	Class II	Active
X-MIND unity	XMU TOP 110 SHORT CONE, INTERF WALL PLATE (16” - 40,64cm)	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V,SHORT CONE,BOTT 80 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND trium	XMT PAN R CEPH R	FDA UDI	Class II	Unknown
xgenus Vega	XG VEGA SIZE 2	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V,SHORT CONE,TOP 40 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND trium	XMT PAN 3D L CEPH L	FDA UDI	Class II	Unknown
U-Sense Hd	U-SENSE HD SIZE 1.5	FDA UDI	Class II	Active
x-mind dc	DC X-MIND 115V VET,SHORT CONE,BOTT 80 (16” - 40,64cm)	FDA UDI	Class II	Active
X-MIND unity	XMU TOP 80 SHORT CONE, INTERF WALL PLATE (16” - 40,64cm)	FDA UDI	Class II	Active

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