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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

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UDI-DI 00850011135495Basic UDI-DI 008500111358017M

Class B · IVDR · LGC Clinical Diagnostics, Inc.

Identification
Model
801mm
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

3832862CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-11-05 · Expiry 2030-06-30

Scope not stated in certificate data.

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

Manufacturer

LGC Clinical Diagnostics, Inc.

SRN US-MF-000029697

US · Cumberland Foreside

manufacturer

Authorised representative: MediMark Europe Sarl. (FR-AR-000000182)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/validate-5495 · UDI page: /udi/00850011135495

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