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Registry EUDAMED 41 FDA 510(k) incl. De Novo FDA PMA GUDID

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Germany 41

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

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Class A 41 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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41 devices foundsorted by relevance

Manufacturer: Seamaty Diagnostic Co., Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

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Class

Automatic Hematology Analyzer

Seamaty Diagnostic Co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:A
Lyse

Seamaty Diagnostic Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A
Diluent

Seamaty Diagnostic Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A
Cleaner

Seamaty Diagnostic Co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:A

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