No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

ARK HS Opiate Control

UDI-DI 00812101031834Basic UDI-DI 0858724003OPI03769

Class B · IVDR · ARK Diagnostics, Inc.

Scan an inventory CSV

Identification

Model: 5037-0001-00
EMDN: W0102152009
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-28 · 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 HS Opiate Assay 00812101031780
ARK HS Opiate Assay 00812101031797
ARK HS Opiate Assay 00812101031773
ARK HS Opiate Assay 00812101032176
ARK HS Opiate Calibrator 00812101031810
ARK HS Opiate Calibrator 00812101031803
ARK HS Opiate Calibrator 00812101031827

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ark-hs-opiate-control-1834 · UDI page: /udi/00812101031834

All devices from ARK Diagnostics, Inc.

Scan an inventory CSV