No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

ARK Fentanyl Calibrator

UDI-DI 00858724003452Basic UDI-DI 0858724003FEN069Y8

Class B · IVDR · ARK Diagnostics, Inc.

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Identification

Model: 5069-0001-00
EMDN: W0102152209
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

ARK Diagnostics, Inc.

SRN US-MF-000023925

US · Fremont

manufacturer

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

Related UDI-DIs

ARK Fentanyl Calibrator 00858724003445
ARK Fentanyl Control 00858724003421
ARK Fentanyl II Assay 00812101030585
ARK Fentanyl II Assay 00812101030561
ARK Fentanyl II Assay 00812101030578

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ark-fentanyl-calibrator-3452 · UDI page: /udi/00858724003452

All devices from ARK Diagnostics, Inc.

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