Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Defibrillator Monitor

UDI-DI 06945429023022Basic UDI-DI 69454290DM003KA

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

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Identification

Model: S2
EMDN: Z1203020201, Z12030502
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

FI23/1008002

EU quality management system · unknown

Notified body: SGS FIMKO OY (0598)

Valid from 2026-06-17 · Expiry 2028-09-05

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

Defibrillator Monitor 06945429023039

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/defibrillator-monitor-3022 · UDI page: /udi/06945429023022

All devices from Shenzhen Comen Medical Instruments Co.,LTD.

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