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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Cometiu

UDI-DI 06974741383538Basic UDI-DI 6974741385003CS

Class III · MDR · Sinomed NeuroVita Technology Inc.

Identification
Model
ISS-2.512-06
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2291466TD02

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-08-06 · Expiry 2031-08-01

Scope not stated in certificate data.

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

2291466CE02

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-08-06 · Expiry 2031-02-01

Scope not stated in certificate data.

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

Manufacturer

Sinomed NeuroVita Technology Inc.

SRN CN-MF-000041241

CN · Su Zhou

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

Related UDI-DIs

Showing 12 of 29 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cometiu-3538 · UDI page: /udi/06974741383538

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