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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Defibrillator monitor

UDI-DI 06945429021264Basic UDI-DI 69454290DM001K6

Class III · MDR · Shenzhen Comen Medical Instruments Co.,LTD.

Identification
Model
S8
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

CN23/00001577

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2025-04-14 · Expiry 2028-03-31

Scope not stated in certificate data.

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

Manufacturer

Shenzhen Comen Medical Instruments Co.,LTD.

SRN CN-MF-000002236

CN · Shenzhen

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/defibrillator-monitor-1264 · UDI page: /udi/06945429021264

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