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UDI Compass
Certificate valid

Snapshot 2026-10-17 · Link to EUDAMED

RightSign

UDI-DI 06934078000362Basic UDI-DI 69340780STA81A00WK

Class B · IVDR · HangZhou Biotest  Biotech Co.,Ltd.

Identification
Model
Cassette, strip
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 077434 0028

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-08-24 · Expiry 2031-08-23

Scope not stated in certificate data.

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

Manufacturer

HangZhou Biotest  Biotech Co.,Ltd.

SRN CN-MF-000008191

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/rightsign-0362 · UDI page: /udi/06934078000362

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