SwissBone ORTHO
by Industrie Biomediche Insubri SA 115 variants
Ref SWO103005
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-07640350051470 07640350051470 | Date15 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
- 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
Specification
- Device Name
- SwissBone ORTHO Cone ∅10x30 mm 5°
- Model / Reference
- SWO103005
- Primary DI / UDI-DI
- 07640350051470
- Basic UDI-DI
- B-07640350051470
- EMDN Code
- P900401 Bone and tendon replacement devices
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000049165
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Other devices from Industrie Biomediche Insubri SA
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