Helix
by SWL Medizin GmbH Germany EUDAMED
Ref MDS809980Model MDS 3D
EMDN Z12109001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1TD-MDR-0065/06/2026/02 | Date5 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- 1TD-MDR-0065/06/2026/02 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2764
- Issued
- 5 Jun 2026
- Expires
- 4 Jun 2029
Specification
- Device Name
- Detachable Coil System
- Model / Reference
- MDS 3D, MDS809980
- Primary DI / UDI-DI
- 04251790299808
- Basic UDI-DI
- 42517902MDS3DG2
- EMDN Code
- Z12109001 Detachable coil equipment for brain aneurysms
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- DE-MF-000008000
Other devices from SWL Medizin GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1b73d603-6cf6-497d-bc5d-6ab8419fdf28