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Results for “SOPHIA”
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EUDAMED
101
FDA 510(k)
2
FDA PMA
GUDID
7
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European Union (all)
101
United States
9
More countries (4)
France
64
Austria
24
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12
Poland
1
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Class I
89
Class IIa
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2
More classes (11)
Class A
9
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IVD General
8
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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2
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110 devices found
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Device · Manufacturer · Authorizations
Verified
Status
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Registry
Class
Versant Sophia Loren 10307068.VER
Fgx International Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Versant Sophia Loren 10307069.VER
Fgx International Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Versant Sophia Loren 10307020.VER
Fgx International Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Vera Bradley VB Sophia Nomadic Floral
Mcgee Group, Inc., The
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Versant Sophia Loren 10307111.VER
Fgx International Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Vera Bradley VB Sophia Imperial Tile
Mcgee Group, Inc., The
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Versant Sophia Loren 10307021.VER
Fgx International Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Petit Sophia
Nishitomo Co., Inc.
·
,
FDA registration: United States
Unclassified
FDA 510(k)
K021978
Active
Cleared 8 Apr 2003
Active
510(k)
510(k)
—
L Sophia
Nishitomo Co., Inc.
·
,
FDA registration: United States
Unclassified
FDA 510(k)
K901512
Active
Cleared 20 Jul 1990
Active
510(k)
510(k)
—
Shower Seat – Sophia 854
REHA FUND Sp. z o.o.
·
,
Poland
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
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