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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

BIOSYNEX

UDI-DI 06977005880057Basic UDI-DI 697700588C00002OZK

Class B · IVDR · Chembio Biosynex Diagnostics (Hangzhou) Inc.

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

V76 122528 0003

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-06-18 · Expiry 2031-06-17

Scope not stated in certificate data.

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

Manufacturer

Chembio Biosynex Diagnostics (Hangzhou) Inc.

SRN CN-MF-000039047

CN · Hangzhou

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biosynex-0057 · UDI page: /udi/06977005880057

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