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Results for “BRERA”
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EUDAMED
12
FDA 510(k) incl. De Novo
1
FDA PMA
GUDID
10
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European Union (all)
12
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11
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Italy
11
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1
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12
Class IIa
6
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3
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2
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IVD General
IVD Annex II List A
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IVD for self-testing
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23 devices found
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Verified
Verified
Status
Status
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Regime
Registry
Registry
Class
Class
Plasmage 1
Brera Medical, Inc.
·
,
FDA registration: United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
Etnia Eyewear Culture 4 BRERA2 56O Slhv
Etnia Barcelona, Llc.
·
,
FDA registration: United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
I
Plasmage System
Brera Medical, Inc.
·
,
FDA registration: United States
FDA 510(k)
K202106
Active
Cleared 6 Apr 2022
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
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