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Results for “GBR KIT”

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Registry EUDAMED 3 FDA 510(k) incl. De Novo FDA PMA GUDID 4

Country / market European Union (all) 2 United States 4

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Czechia 2

Risk class Class I 2 Class IIa 2 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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4 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Save Gbr Kit Dgkt

Dentis Co., Ltd,FDA registration: South Korea

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I
Gbr Kit

Osstem Implant Co., Ltd,South Korea Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa
Sinus & GBR Kit SGK

Ossvis Co., Ltd.,South Korea

None Registry: GUDID Class:I

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