Skeletal Dynamics Bone Contouring Instruments
by Skeletal Dynamics, Inc. EUDAMED
Active
Ref RMR-CV-01Model BC-FAM
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0841506143896U | Date2 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- BC-FAM, RMR-CV-01
- Primary DI / UDI-DI
- 00841506109312
- Basic UDI-DI
- 0841506143896U
- EMDN Code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000041441
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Skeletal Dynamics, Inc
Properties
Other properties (12)
- Sterile: No
- Implantable: 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