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Variants of SkyPulse by FOTONA, proizvodnja optoelektronskih naprav d.o.o.
4 variants
Key
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
SkyPulse
UDI-DI 03830054230927
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
FDA 510(k)
K193656
Active
Cleared 27 Mar 2020
CE/MDR
+1
authorizations
Active
Regimes:
CE MDR
510(k)
Registry:
EUDAMED
GUDID
Class
Class:
IIb
SkyPulse
UDI-DI 03830054230392
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
SkyPulse
UDI-DI 03830054230408
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
SkyPulse
UDI-DI 03830054230934
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
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