DERIVO 2heal Embolisation Device
by Acandis GmbH EUDAMED
Active
Ref 01-104032
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000331236 | Date6 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- 1000264699 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 29 Sep 2025
- Expires
- 28 Sep 2030
- 1000331236 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 6 Aug 2026
- Expires
- 22 Mar 2028
- Reason
- Change approved
Specification
- Model / Reference
- 01-104032
- Primary DI / UDI-DI
- 04260650337246
- Basic UDI-DI
- 426065033DERIVO2healUN
- Direct Marketing DI
- 04260650337246
- EMDN Code
- P0799 Vascular and cardiac prostheses - other
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006259
Other devices from Acandis GmbH
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No