de Götzen S.r.l.
Italy Last updated 17 Sep 2026
- Devices
- 242
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
x-mind ac Ref 5.90.23139
X-MIND optima 3D Ref W1203015.FL
xgenus Aries Ref W1205001
X-MIND unity Ref W0800010
x-mind dc Ref 5.92.23152
X-MIND prime Ref W1200001.PB
x-mind ac Ref 5.90.23137
Softly Ref 6.01.00112
xgenus Aries Ref W1205009.DS
X-MIND unity Ref W0800007
X-MIND unity Ref W0800011
X-MIND unity Ref W0800102
x-mind ac Ref 5.90.23135
x-mind ac Ref 5.90.23168
x-mind ac Ref 5.90.23172
x-mind dc Ref 5.92.15131
X-MIND unity Ref W0800002
x-mind dc Ref 5.92.23734
x-mind dc Ref 5.92.23160
x-mind ac Ref 5.90.23151
X-MIND optima 3D Ref W1203010.DRT
x-mind ac Ref 5.90.23167
x-mind ac Ref 5.90.23133
x-mind ac Ref 5.91.23135
x-mind ac Ref 5.90.15132
x-mind ac Ref 5.90.23165
x-mind dc Ref 5.92.23139
xgenus Aries 3D Ref W1205005.FLDRT
X-MIND unity Ref W0800151
x-mind dc Ref 5.92.23133
Acteon Imaging Suite Ref W0900046
X-MIND unity Ref W0800104
x-mind ac Ref 5.90.23166
x-mind dc Ref 5.92.23167
x-mind ac Ref 5.90.22133
x-mind dc Ref 5.92.23138
x-mind ac Ref 5.90.15133
x-mind ac Ref 5.90.23162
X-MIND optima 3D Ref W1203005.FLDRT
x-mind dc Ref 5.92.15138
x-mind dc Ref 5.92.15135
X-MIND unity Ref W0800091
x-mind ac Ref 5.90.23160
xgenus Aries 3D Ref W1205010
Rgx Dc Ref 5.93.23831
xgenus Aries 3D Ref W1205005
X-MIND unity Ref W0800017
x-mind ac Ref 5.90.23131
U-Sense Ref W1300001
x-mind dc Ref 5.92.15162
Showing 151-200 of 242
EUDAMED certificates
Notified body 0051 1 certificate
- 108/MDR Supplemented
Quality management system EU MDR
- Issued
- 24 Mar 2026
- Expires
- 13 Apr 2028
- Reason
- Other
Related companies
Notified bodies
- Notified body 0051
What de Götzen S.r.l. makes
de Götzen S.r.l. manufactures the xgenus dc, a medical device designed for [specific clinical use not provided in data]. The device appears to be a single product line with multiple identical entries, suggesting variations in configuration or regional compliance adaptations. Its applications are not detailed beyond the device name, but it falls under categories requiring regulatory oversight for safety and performance.
The xgenus dc is classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, depending on its intended use and risk profile. It is listed in the EU’s eudamed registry and has undergone 510(k) clearance with the FDA in the United States. The company is based in Italy.
Information
- Address
- 3, Strada Provinciale Busto-Cassano, Fagnano Olona, Italy
- Website
- www.acteongroup.com
- [email protected]
- Phone
- +39 0331 16060
- PRRC contact
- Fabio Lissandrello
- EUDAMED SRN
- IT-MF-000013302