Company

Quality Management

Both Nefes device families are CE-certified under the EU Medical Devices Regulation. Quality is designed into the product and verified by an independent notified body.

Regulation

MDR (EU) 2017/745

Standard

EN ISO 80601-2-72

Notified Body

UDEM Adriatic d.o.o. (NB 2696)

Manufacturer SRN

TR-MF-000038588

CE Certificates

Class IIb

Ventisense Mechanical Ventilator

Certificate: M.2025.MDR.1073
Basic UDI-DI: 868419012ventisenseFU
EMDN: Z1203010504
GMDN: 47083
Valid until: 04.05.2029

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Class IIa

AirPAP Respiratory Therapy Device

Certificate: M.2025.MDR.1074
Basic UDI-DI: 868419012SDCV4AIRPAP3S
EMDN: Q03010299
Valid until: 04.05.2030

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