Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Sapphire ULTRA

UDI-DI 06934955979101Basic UDI-DI 693495597912B

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

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Identification

Model: —
EMDN: C010401020101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 797598

EU technical documentation assessment · unknown

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

Valid from 2026-08-18 · Expiry 2029-07-31

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)

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Showing 12 of 44 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sapphire-ultra-9101 · UDI page: /udi/06934955979101

All devices from OrbusNeich Medical (Shenzhen) Co.,Ltd

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