Basic Emergency Kit - without manual bag
by Noxtec Development S.L. Spain EUDAMED
Ref P000737
EMDN R020108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8437023061NTXEmergKitsQM | Date28 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NTXEmergencyKits
- Model / Reference
- P000737
- Primary DI / UDI-DI
- 08437023061213
- Basic UDI-DI
- 8437023061NTXEmergKitsQM
- EMDN Code
- R020108 Respiratory gas monitoring and sampling circuits and kits
- Device Class
- Class IIa
- Medical Purpose
- The emergency kit is intended to provide immediate access to compatible CE-marked medical devices required to connect a nitric oxide delivery system to a ventilator and patient interface during critical care interventions. It is designed to facilitate rapid setup and support the timely administration of inhaled nitric oxide therapy. The kit does not introduce a new intended medical purpose and is limited to facilitating the combined emergency use of the included devices within their specified intended uses.
Manufacturer details
- EUDAMED SRN
- ES-PR-000045101
Other devices from NOXtec Development S.L.
Properties & raw data
Show properties, registry sources and raw records
Other properties (1)
- Sterile: No
Sources (1)
- EUDAMED 2820cae9-8a3e-46be-bf2f-3ec8082e1948