← Back to catalogue
Set Monitorización Brizzy NJ Pk10
EUDAMEDClass I (EU MDR)
Ref NS010NJ
by Prim, S.a.
Identity
- Trade Name
- Set Monitorización Brizzy NJ Pk10 EUDAMED
- Device Name
- Agrupaciones Apnea EUDAMED
- Model / Reference
- NS010NJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048504749 EUDAMED
- Basic UDI-DI
- 843404825APNEAAA EUDAMED
- EMDN Code
- Z12080406 APNOEA MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Agrupaciones que recogen los dispositivos necesarios para realizar diagnóstico y tratamiento de desórdenes respiratorios durante el sueño con distintas configuraciones según las necesidades de los servicios y los centros. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Set Monitorización Brizzy NJ Pk10 by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843404825APNEAAA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED d53ac3f0-bb46-4ae3-b30d-0d679180ab0b 61 fields · synced Jun 18, 2026