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No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

ARK Fentanyl II Assay

UDI-DI 00812101030578Basic UDI-DI 0858724003FEN069Y8

Class B · IVDR · ARK Diagnostics, Inc.

Identification
Model
5069-0001-00
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

ARK Diagnostics, Inc.

SRN US-MF-000023925

US · Fremont

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ark-fentanyl-ii-assay-0578 · UDI page: /udi/00812101030578

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