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Results for “XP-4D MEDIUM”
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EUDAMED
4
FDA 510(k) incl. De Novo
FDA PMA
GUDID
2
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European Union (all)
4
United States
2
More countries (1)
France
4
Risk class
Class I
2
Class IIa
4
Class IIb
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More classes (11)
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IVD General
IVD Annex II List A
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IVD for self-testing
Active implantable (AIMDD)
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6 devices found
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Device · Manufacturer · Authorizations
Verified
Verified
Status
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Regime
Registry
Registry
Class
Class
XP-4D PP-Medium
Sure Dent Corporation
·
,
FDA registration: South Korea
GUDID
not on market
Withdrawn
Registry:
GUDID
Class
Class:
I
XP-4D GP-Medium
Sure Dent Corporation
·
,
FDA registration: South Korea
GUDID
not on market
Withdrawn
Registry:
GUDID
Class
Class:
I
Xp-4D Medium
FKG Dentaire Sàrl
·
,
Switzerland
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
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