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UDI Compass

ARK HS Opiate Assay

No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00812101031797Basic UDI-DI 0858724003OPI03769

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Class B · IVDR · ARK Diagnostics, Inc.

Identification

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

Certificates

No certificate found.

Snapshot 2026-10-31 · 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

NameUDI-DICertificate
ARK HS Opiate Assay00812101031780
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Assay00812101031773
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Assay00812101032176
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Calibrator00812101031810
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Calibrator00812101031803
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Calibrator00812101031827
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

ARK HS Opiate Control00812101031834
No Certificate Found

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ark-hs-opiate-assay-1797 · UDI page: /udi/00812101031797

All devices from ARK Diagnostics, Inc.