Results for “Plastic Spectacle Frames Without Lenses”

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Registry EUDAMED 359 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 358

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Spain 356 Hungary 2

Risk class Class I 359 Class IIa 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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Plastic Spectacle Frames Without Lenses

Wenzhou Yabao Optical Co., Ltd,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Plastic Spectacle Frames Without Lenses

Wenzhou Eyestar Eyewear Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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deviCERTS Global Medical Device Regulatory Database

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