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Registry EUDAMED 65 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 65

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Netherlands 65

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

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Class A Class B 65 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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65 devices foundsorted by relevance

Manufacturer: Biologicals Quality Control B.V.× Clear all

Device · Manufacturer · Authorizations

P0317 SeraQ Alinity Syphilis UDI-DI 08718719833858

Biologicals Quality Control B.V.,Netherlands Class B

Active CE IVDR EUDAMED B
2 variants
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P0064 ViraQ HIV-1 Check 125 UDI-DI 08718719832783

Biologicals Quality Control B.V.,Netherlands Class B

Active CE IVDR EUDAMED B
2 variants
- See all variants of this device
P0386 SeraQ Alinity V4 UDI-DI 08718719833902

Biologicals Quality Control B.V.,Netherlands Class B

Active CE IVDR EUDAMED B
2 variants
- See all variants of this device
P0063 ViraQ HCV Check 125 UDI-DI 08718719832776

Biologicals Quality Control B.V.,Netherlands Class B

Active CE IVDR EUDAMED B
2 variants
- See all variants of this device
P0260 SeraQ Murex Syphilis UDI-DI 08718719833780

Biologicals Quality Control B.V.,Netherlands Class B

Active CE IVDR EUDAMED B
2 variants
- See all variants of this device

Showing 61-65 of 65

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