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Device · Manufacturer · Authorizations
Verified
Verified
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Regime
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Class
Class
Digital Chart, Chart Projector, Visual Acuity Chart System
Huvitz Co., Ltd.
·
,
South Korea
Group of variants
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
Visibly Digital Acuity Product (VDAP)
Visibly, Inc.
·
,
United States
FDA 510(k)
K220090
Active
Cleared 12 Aug 2022
CE/MDR
+1
authorizations
Active
Regimes:
CE MDR
510(k)
Registry:
EUDAMED
GUDID
Class
Class:
IIa
Acuity™
Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
·
,
United States
Group of variants
CE/MDR
MDR 790667
Active
Valid to Apr 2029
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
III
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