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Kubala External Ventricular Catheter (large Lumen)
EUDAMEDClass III (EU MDR)
Ref DE-105
by Sophysa
Identity
- Trade Name
- KUBALA EXTERNAL VENTRICULAR CATHETER (LARGE LUMEN) EUDAMED
- Device Name
- External Ventricular Catheter (Large Lumen) EUDAMED
- Model / Reference
- DE-105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124131871 EUDAMED
- Basic UDI-DI
- B-03760124131871 EUDAMED
- EMDN Code
- N010303 CEREBRAL FLUID EXTERNAL DRAINS AND KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kubala External Ventricular Catheter (large Lumen) by Sophysa — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760124131871 | Class III | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (1)
- EUDAMED 9d6cf223-a5ce-4e8e-b5ef-397cda18b3db 61 fields · synced Jul 9, 2026