Exabone Ha/Tcp
by Exabone GmbH EUDAMED
Active
Ref 07000103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764015324HATCP7U | Date4 May 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- Withdrawn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 769693 Amended
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 7 Aug 2024
- Expires
- 12 Feb 2028
- Reason
- Other
Specification
- Device Name
- Exabone Ha/Tcp
- Model / Reference
- 07000103
- Primary DI / UDI-DI
- 07640153242570
- Basic UDI-DI
- 764015324HATCP7U
- EMDN Code
- P900401 Bone and tendon replacement devices
- Device Class
- Class III
- Market of Registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CH-MF-000015651
- Authorised representative
- Medical Device Management Ltd IE-AR-000002496
Other devices from Exabone 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