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Registry EUDAMED FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) United States

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Risk class Class I Class IIa Class IIb Class III Class II (US)

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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406 devices foundsorted by relevance

Manufacturer: EnSafe Sp. z o.o.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Everest 2.0

EnSafe Sp. z o.o.,Poland Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Robin 2.0

EnSafe Sp. z o.o.,Poland Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Reptor

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
Falcon 2.0

EnSafe Sp. z o.o.,Poland Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

Showing 61-80 of 406

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