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UDI Compass
Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Disposable face mask

UDI-DI 06974843124855Basic UDI-DI 697484312PB001-2CA

Class Is · MDR · ZOGEAR Medical Co., Ltd.

Identification
Model
PB001-2
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

EPT 0477.MDR.26/6311

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2026-10-02 · Expiry 2031-10-01

Scope not stated in certificate data.

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

Manufacturer

ZOGEAR Medical Co., Ltd.

SRN CN-MF-000012353

CN · Yizheng

manufacturer

Authorised representative: Luxus Lebenswelt GmbH (DE-AR-000005110)

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/disposable-face-mask-4855 · UDI page: /udi/06974843124855

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