Identity
- Trade Name
- KIT R400+B800+DREPLANC/T EUDAMED
- Device Name
- Agrupaciones de Drenaje EUDAMED
- Model / Reference
- KIT-503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048058846 EUDAMED
- Basic UDI-DI
- 843404825KITDRENAJES9J EUDAMED
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Agrupaciones de material fungible de drenaje para cirugías. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Kit R400+b800+dreplanc/T by Prim S.a. — Class IIa — 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 | 843404825KITDRENAJES9J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED de9d6ff1-750f-4264-b1b6-bd87558902f8 61 fields · synced Jun 19, 2026