Kit NTX2000 for 15mm
by Noxtec Development S.L. Spain EUDAMED
Ref P000717
EMDN R020108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8437023061NoxtecKits7Y | Date28 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NTX1000Kits
- Model / Reference
- P000717
- Primary DI / UDI-DI
- 08437023061435
- Basic UDI-DI
- 8437023061NoxtecKits7Y
- EMDN Code
- R020108 Respiratory gas monitoring and sampling circuits and kits
- Device Class
- Class IIa
- Medical Purpose
- The procedure pack is intended to assemble CE-marked medical devices to enable the connection of a nitric oxide delivery system to a ventilator and patient interface, in order to support the administration of inhaled nitric oxide therapy. The procedure pack does not introduce a new intended medical purpose and is limited to facilitating the combined 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 08437023061435|8437023061NOXTECKITS7Y