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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Xtenza

UDI-DI 06934955914959Basic UDI-DI 69349559571ZQ

Class III · MDR · OrbusNeich Medical (Shenzhen) Co.,Ltd

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

MDR 776474

EU technical documentation assessment · unknown

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

Valid from 2026-08-18 · Expiry 2028-06-18

Scope not stated in certificate data.

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

Manufacturer

OrbusNeich Medical (Shenzhen) Co.,Ltd

SRN CN-MF-000011345

CN · People's Republic of China

manufacturer

Authorised representative: Quality First International OÜ (EE-AR-000004308)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/xtenza-4959 · UDI page: /udi/06934955914959

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