Michelangelo Hand
by Otto Bock Healthcare Products GmbH 2 variants
Ref 8E500=R-MModel 8E500
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number40644110000000008E500KX 04064411258043 | Date14 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 8E500, 8E500=R-M
- Primary DI / UDI-DI
- 04064411258043
- Basic UDI-DI
- 40644110000000008E500KX
- EMDN Code
- Y061899 Upper extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- AT-MF-000002920
Other devices from Otto Bock Healthcare Products GmbH
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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