Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

Ventilator

UDI-DI 06945429023350Basic UDI-DI 69454290GV002N8

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

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Identification

Model: V8
EMDN: Z1203010504
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

Ventilator 06945429023381
Ventilator 06945429023343
Ventilator 06945429023367
Ventilator 06945429023336
Ventilator 06945429023374

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ventilator-3350 · UDI page: /udi/06945429023350

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

Scan an inventory CSV