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Results for “PROFILER”

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Registry EUDAMED 776 FDA 510(k) incl. De Novo 21 FDA PMA GUDID 329

Country / market European Union (all) 684 United States 349

More countries (12)

Italy 512 Czechia 60 Germany 26 Netherlands 25 Ireland 20 Romania 17 Spain 10 Greece 8 Poland 4 Türkiye 2 France 1 Sweden 1

Risk class Class I 261 Class IIa 619 Class IIb 15 Class III 4 Class II (US) 54

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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Category (EMDN)

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953 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Surgical instruments

Biotec S.R.L.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bone profiler M

Alpha Bio Tec Ltd.,Israel

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bone Profiler

LASAK s.r.o.,Czechia

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bone Profiler

Megagen Implant Co., Ltd.,South Korea

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Showing 181-200 of 953

deviCERTS Global Medical Device Regulatory Database

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