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Results for “A01132”
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EUDAMED
3
FDA 510(k) incl. De Novo
FDA PMA
GUDID
1
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European Union (all)
3
United States
1
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Italy
3
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4
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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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2 devices found
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Verified
Verified
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Class
Class
optical
Wenzhou Well Optical Co., Ltd
·
,
China
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
Genemed® 61-0186
Sakura Finetek USA, Inc
·
,
United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
I
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