Identity
- Trade Name
- Set Inicio Apneaguard S/C EUDAMED
- Device Name
- Agrupaciones Apnea EUDAMED
- Model / Reference
- 25-100X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048535088 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 Inicio Apneaguard S/C 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 |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED 131f13d7-491f-44ba-ad26-cad49b930c9c 61 fields · synced Jul 16, 2026