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External Lumbar Catheter With Introducer Guide
EUDAMEDClass III (EU MDR)
Ref DE-109
by Sophysa
Identity
- Trade Name
- EXTERNAL LUMBAR CATHETER WITH INTRODUCER GUIDE EUDAMED
- Device Name
- External Lumbar Catheter With Introducer Guide EUDAMED
- Model / Reference
- DE-109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124130218 EUDAMED
- Basic UDI-DI
- B-03760124130218 EUDAMED
- EMDN Code
- N010303 CEREBRAL FLUID EXTERNAL DRAINS AND KITS EUDAMED
Classification
- Device Class
- Class III 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
External Lumbar Catheter With Introducer Guide 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-03760124130218 | Class III | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (1)
- EUDAMED 8604fb3c-3fa5-46bb-b8bc-db39afc9c48f 61 fields · synced Jun 19, 2026