No specific devices are listed for this certificate.
Characteristics
Sterile
No
Human tissues
Yes
Animal tissues
No
In vitro diagnostics
—
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
—
SPP applicable
—
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others
History
No status changes or preceding certificates are recorded.
Scope coverage
IVDR Class B1
1 scope
CLINICAL CHEMISTRY
IVR 0601: Devices intended to be used for
screening/confirmation of specific disorders/impairments
W01019099 - CLINICAL CHEMISTRY REAGENTS – OTHER