Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

Ventilator

UDI-DI 06945429025019Basic UDI-DI 69454290GV003NA

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

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Identification

Model: NV50, NV50A, NV50B, NV60, NV60A, NV60B, NV70, NV70A, NV70B
EMDN: Z1203010504, Z1203020299
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: Yes

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)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ventilator-5019 · UDI page: /udi/06945429025019

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

Scan an inventory CSV