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EUDAMED
15
FDA 510(k) incl. De Novo
FDA PMA
GUDID
1
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European Union (all)
15
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1
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4
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15
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IVD General
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IVD for self-testing
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16 devices found
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Verified
Verified
Status
Status
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Regime
Registry
Registry
Class
Class
Nyda
G. Pohl-Boskamp GmbH & Co. KG
·
,
Germany
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Unimed NYDA1125
Unimed Medical Supplies, Inc.
·
,
China
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
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