Identity
- Trade Name
- Helix EUDAMED
- Device Name
- Detachable Coil System EUDAMED
- Model / Reference
- MDS 10 EUDAMEDMDS831860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790218601 EUDAMED
- Basic UDI-DI
- 42517902MDS10EN EUDAMED
- EMDN Code
- Z12109001 DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Helix by SWL Medizin GmbH — Class III — 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 | 42517902MDS10EN | Class III | Active |
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Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (1)
- EUDAMED 16ccadd2-c6f9-4c8c-924d-03ce22a81133 61 fields · synced Jul 8, 2026