Identity
- Trade Name
- EchoTip Insight® EUDAMED
- Device Name
- EchoTip Insight® Portosystemic Pressure Gradient EUDAMED
- Model / Reference
- ECHO-PPG-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002580008 EUDAMED
- Basic UDI-DI
- 0827002CIRL202003061002AC EUDAMED
- EMDN Code
- G030899,Z1203020302 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The EchoTip Insight® Portosystemic Pressure Gradient Procedure Pack (ECHO-PPG-I) is intended to provide mutually compatible medical devices to allow for direct pressure measurement and monitoring in the hepatic and portal veins or their branches in patients with portal hypertension. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
EchoTip Insight® by Cook Ireland Limited — 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 | 0827002CIRL202003061002AC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cook Ireland
- EUDAMED SRN
- IE-PR-000002461
Sources (1)
- EUDAMED 262a58cd-5264-4f45-b4ee-ab15c22f535b 61 fields · synced Jul 14, 2026