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Results for “Optitrol Blue”

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Registry EUDAMED 6 FDA 510(k) incl. De Novo FDA PMA GUDID 3

Country / market European Union (all) 6 United States 3

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Germany 3 Ireland 3

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

More classes (11)

Class A Class B 5 Class C Class D IVD General IVD Annex II List A 1 IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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6 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Registry

Class

Optitrol Blue

LGC Clinical Diagnostics, Inc.,United States Group of variants

Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:B
Optitrol Blue

DiaMex GmbH,Germany Group of variants

Withdrawn Regimes: CE IVDR, withdrawn CE IVDD, withdrawn Registry: EUDAMED Class:B
Optitrol Blue

DiaMex GmbH,Germany

Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED Class:IVD Annex II List A

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