Identity
- Trade Name
- Set Cribado Neonatal Clip 20 EUDAMED
- Device Name
- Agrupaciones Cribado ORL EUDAMED
- Model / Reference
- PM0101C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048349715 EUDAMED
- Basic UDI-DI
- 843404825KITCRIBADOBW EUDAMED
- EMDN Code
- Z12140385 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Pruebas con equipos de potenciales evocados auditivos de tronco cerebral que hagan la prueba de potenciales evocados auditivos automáticos (prueba AABR) en unidades de: • Otorrinolaringología (Audiología) • Pediatría • Neonatología • Neurofisiología EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Set Cribado Neonatal Clip 20 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 | 843404825KITCRIBADOBW | 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 fbe34d11-7046-4f2f-840c-5a26f0f8ed5f 61 fields · synced Aug 1, 2026