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Registry EUDAMED FDA 510(k) 23 FDA PMA GUDID

Country / market United States 23

Risk class Class I 6 Class IIa Class IIb Class III Class II (US) 17

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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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23 devices foundsorted by relevance

Manufacturer: Harleco Diagnostics× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Auto-Albumin Reag For Gilford 3400E Anal

Harleco Diagnostics,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
Ultrachem Phos

Harleco Diagnostics,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Ldh Ultrazyme Plus

Harleco Diagnostics,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 21-23 of 23

deviCERTS Global Medical Device Regulatory Database

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