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Results for “LUA”

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Registry EUDAMED 8 FDA 510(k) incl. De Novo FDA PMA 1 GUDID 15

Country / market European Union (all) 8 United States 16

More countries (4)

Germany 4 Spain 2 Malta 1 Netherlands 1

Risk class Class I 4 Class IIa Class IIb 1 Class III 16 Class II (US)

More classes (11)

Class A Class B Class C 1 Class D IVD General 2 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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24 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Lua

SOFTLINE-Schaum GmbH & Co. KG,Germany Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Optune Lua®

Novocure GmbH,Switzerland

Active Regimes: CE MDR PMA Registry: PMA Class:III
Optune Lua

Novocure GmbH,Switzerland

Expiring Regimes: CE MDR Registry: EUDAMED Class:IIb

Showing 21-24 of 24

deviCERTS Global Medical Device Regulatory Database

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