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Results for “Smartex”

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

Country / market European Union (all) 6 United States 1

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Greece 6

Risk class Class I 8 Class IIa Class IIb Class III Class II (US) 1

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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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9 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Registry

Class

Smartex

St.Marys Rubbers Pvt. Ltd.,India Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Smartex Plus

St.Marys Rubbers Pvt. Ltd.,India

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:I
Nonagon N9+ SmartExam

Nonagon, Ltd.,Israel(FDA applicant)

None Registry: GUDID Class:II

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