IntraumaBone
by Ceramisys Limited EUDAMED
Active
Ref INB-W30351005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506017162HATCPZ9 | Date14 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Not drawn on the map: Northern Ireland.
- 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
- MDR 780338 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 21 May 2026
- Expires
- 20 May 2031
Specification
- Device Name
- Hatcp
- Model / Reference
- INB-W30351005
- Primary DI / UDI-DI
- 05060171626527
- Basic UDI-DI
- 506017162HATCPZ9
- EMDN Code
- P900401 Bone and tendon replacement devices
- Device Class
- Class III
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000008083
- Authorised representative
- Medical Device Management Ltd IE-AR-000002496
Other devices from Ceramisys Ltd
Properties
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