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Results for “iiSi”
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EUDAMED
4
FDA 510(k) incl. De Novo
1
FDA PMA
GUDID
1
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European Union (all)
4
United States
2
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4
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4
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1
More classes (11)
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IVD General
IVD Annex II List A
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IVD for self-testing
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6 devices found
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Class
Class
Eclipse MicroPen Elite MP1001-IISilver
Eclipse, Inc.
·
,
FDA registration: United States
GUDID
not on market
Withdrawn
Registry:
GUDID
Class
Class:
—
iiSi
Blue Sail Medical Co., Ltd
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
Iisis, Version 1.0
Innovision Medical Technologies, LLC
·
,
FDA registration: United States
FDA 510(k)
K052244
Active
Cleared 13 Oct 2005
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
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