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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-19 · Link to EUDAMED

PRIMA HOME TEST

UDI-DI 07640164861487Basic UDI-DI 764016486HGEH8B6

Class B · IVDR · PRIMA Lab SA

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

D1408400113

EU technical documentation assessment · unknown

Notified body: mdc medical device certification GmbH (0483)

Valid from 2026-07-14 · Expiry 2028-10-25

Scope not stated in certificate data.

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

Manufacturer

PRIMA Lab SA

SRN CH-MF-000034473

CH · Morbio Inferiore

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prima-home-test-1487 · UDI page: /udi/07640164861487

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