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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

epoc BGEM Test Cards

UDI-DI 00809708121860Basic UDI-DI 0405686901913VY

Class C · IVDR · Epocal Inc.

Identification
Model
IVDR_69_OTT_DUB-C_C_NPT_REAG_BG-EPOC
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2262557-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2023-10-30 · Expiry 2027-06-09

Scope not stated in certificate data.

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

Manufacturer

Epocal Inc.

SRN CA-MF-000017182

CA · Ottawa

manufacturer

Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited (IE-AR-000006763)

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/epoc-bgem-test-cards-1860 · UDI page: /udi/00809708121860

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