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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

hCG One Step Pregnancy Test

UDI-DI 06939663910569Basic UDI-DI 693966391HCG0002MX

Class B · IVDR · Sejoy Biomedical Co., Ltd.

Identification
Model
WhCG-1111,WhCG-1112,WhCG-1113,WhCG-1113a, WhCG-1113b
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IVDR 838352

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-04 · Expiry 2031-08-03

Scope not stated in certificate data.

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

Manufacturer

Sejoy Biomedical Co., Ltd.

SRN CN-MF-000008447

CN · Hangzhou City

manufacturer

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

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/hcg-one-step-pregnancy-test-0569 · UDI page: /udi/06939663910569

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