de Götzen S.r.l.
Italy Last updated 17 Sep 2026
- Devices
- 242
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
X-MIND optima 3D Ref W1203005.DRT
X-MIND prime 3D Ref W1200020
xgenus Aries 3D Ref W1205005.DRT
x-mind dc Ref 5.93.23231
X-MIND optima 3D Ref W1203015
x-mind ac Ref 5.90.23138
X-MIND optima 3D Ref W1203005
X-MIND unity Ref W0800106
x-mind dc Ref 5.92.23161
x-mind dc Ref 5.92.23531
x-mind dc Ref 5.92.23985
U-Sense Ref W1300002
x-mind ac Ref 5.90.22135
Rgx Dc Ref 5.93.23832
x-mind dc Ref 5.92.15163
x-mind dc Ref 5.92.15134
x-mind ac Ref 5.90.23161
xgenus Aries 3D Ref W1205010.DRT
X-MIND unity Ref W0800000
x-mind dc Ref 5.92.23537
X-MIND optima 3D Ref W1203010
x-mind ac Ref 5.90.22132
Rgx Dc Ref 5.92.23832
X-MIND prime Ref W1200001.FL
x-mind dc Ref 5.92.23168
U-Sense Hd Ref W1300004
x-mind ac Ref 5.91.23231
x-mind dc Ref 5.92.23978
x-mind dc Ref 5.92.23135
U-Sense Hd Ref W1300003
x-mind ac Ref 5.90.23985
x-mind dc Ref 5.92.23163
X-MIND optima 3D Ref W1203005.FL
X-MIND prime 3D Ref W1200005
x-mind ac Ref 5.90.15136
x-mind ac Ref 5.90.23136
x-mind dc Ref 5.92.23150
x-mind ac Ref 5.90.23163
x-mind ac Ref 5.90.22131
x-mind dc Ref 5.92.15166
x-mind ac Ref 5.90.15130
X-MIND unity Ref W0800009
Showing 201-242 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