Results for “STERILIZATION PACKAGING”

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Registry EUDAMED 464 FDA 510(k) incl. De Novo 32 FDA PMA GUDID 124

Country / market European Union (all) 463 United States 156

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Germany 135 Spain 122 Austria 73 Bulgaria 44 Poland 44 Denmark 41 Slovenia 2 Belgium 1 Italy 1

Risk class Class I 468 Class IIa Class IIb Class III Class II (US) 31

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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) 1 Not classified (FDA)

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Sterilization Packaging

Bolsaplast, S.L.,Spain Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Arrowpack Transparent Sterilization Packaging

SAN.KO.M. d.o.o.,Slovenia

Active Regimes: CE MDD Registry: EUDAMED Class:I

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Results for “STERILIZATION PACKAGING”

Category (EMDN)

Sterilization Packaging

Arrowpack Transparent Sterilization Packaging