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UDI Compass

RealTime

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00884999001534Basic UDI-DI 0884999RTG00027J

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Class D · IVDR · Abbott Molecular Inc.

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

IVDR 798927

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-05-01 · Expiry 2029-07-15

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Abbott Molecular Inc.

SRN US-MF-000017776

US · Des Plaines, IL

manufacturer

Authorised representative: Abbott GmbH (DE-AR-000009457)

Related UDI-DIs

NameUDI-DICertificate
RealTime00884999001497
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/realtime-1534 · UDI page: /udi/00884999001534

All devices from Abbott Molecular Inc.