No specific devices are listed for this certificate.
Characteristics
Sterile
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others
History
No status changes or preceding certificates are recorded.
Scope coverage
Class I1
1 scope
Products of class I, reusable surgical instruments:
Z120114 – Surgical Navigation Instruments
The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.