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Results for “Axiom”
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EUDAMED
~1,844
FDA 510(k) incl. De Novo
FDA PMA
GUDID
~1,058
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European Union (all)
~1,569
United States
~1,058
More countries (5)
Sweden
~733
Germany
~421
France
~382
Italy
~24
Portugal
~9
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Class I
~1,583
Class IIa
~6
Class IIb
~357
Class III
Class II (US)
~54
More classes (11)
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IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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Device · Manufacturer · Authorizations
Verified
Verified
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Regime
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Class
Class
Axiom
Ki Mobility, LLC
·
,
United States
Group of variants
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
Axiom P
Ki Mobility, LLC
·
,
United States
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
Axiom PXP
Ki Mobility, LLC
·
,
United States
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
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