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Registry EUDAMED ~400 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~400

More countries (4)

Poland ~387 Austria ~9 Finland ~3 Bulgaria ~1

Risk class Class I ~400 Class IIa Class IIb Class III Class II (US)

More classes (11)

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

Robin 2.0

EnSafe Sp. z o.o.,Poland

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

EnSafe Sp. z o.o.,Poland

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

EnSafe Sp. z o.o.,Poland

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

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I

Showing 341-360 of 406

deviCERTS Global Medical Device Regulatory Database

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