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Withdrawn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Withdrawn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