No Certificate Found

Snapshot 2026-10-10 · Link to EUDAMED

ORAgene ONE

UDI-DI 00627595000620Basic UDI-DI 0627595E0500GF

Class A · IVDR · DNA Genotek Inc.

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Identification

Model: —
EMDN: W05019002
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-10 · Link to EUDAMED

Manufacturer

DNA Genotek Inc.

SRN CA-MF-000003486

CA · Ottawa

manufacturer

Authorised representative: QbD RepS BV (BE-AR-000000040)

Related UDI-DIs

ORAgene DNA 00627595000651
ORAgene DNA 00627595000590
ORAgene DNA 00627595000583
ORAgene DNA 00627595000613
ORAgene Dx 00627595000026
ORAgene Dx 00627595000248
ORAgene Dx 00627595000255
ORAgene Dx 00627595000019
ORAgene Dx 00627595000132
ORAgene ONE 00627595000637

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/oragene-one-0620 · UDI page: /udi/00627595000620

All devices from DNA Genotek Inc.

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