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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

HIVFIND Whole Blood HIV 1/2 antibody detection self test

UDI-DI 08905459004765Basic UDI-DI 8905459HIVWBSFEL

Class D · IVDR · Meril Diagnostics Pvt. Ltd.

Identification
Model
HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

2024-IVDR/TD-003/A

EU technical documentation assessment · unknown

Notified body: 3EC International a.s. (2265)

Valid from 2026-06-30 · Expiry 2028-09-09

Scope not stated in certificate data.

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

2024-IVDR/QS-003/A

EU quality management system · unknown

Notified body: 3EC International a.s. (2265)

Valid from 2026-06-30 · Expiry 2028-09-09

Scope not stated in certificate data.

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

Manufacturer

Meril Diagnostics Pvt. Ltd.

SRN IN-MF-000028158

IN · Vapi

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hivfind-whole-blood-hiv-1-2-antibody-detection-self-test-4765 · UDI page: /udi/08905459004765

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