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External Neurological Drainage System
EUDAMEDClass IIa (EU MDR)
Ref DE-210
by Sophysa
Identity
- Trade Name
- EXTERNAL NEUROLOGICAL DRAINAGE SYSTEM EUDAMED
- Device Name
- External Neurological Drainage System EUDAMED
- Model / Reference
- DE-210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124130225 EUDAMED
- Basic UDI-DI
- B-03760124130225 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
External Neurological Drainage System by Sophysa — Class IIa — 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-03760124130225 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (1)
- EUDAMED cb865367-ed18-485e-bb30-668f887eb3f3 61 fields · synced Jun 18, 2026