LUNAneo1arm Self-Fabrication
Ref 133-022/133-023/133-024/133-025Model neo1
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 | Number426075088NEOHX 04260750882943 | Date11 Jan 2024 | 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- Withdrawn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
- neo1, 133-022/133-023/133-024/133-025
- Primary DI / UDI-DI
- 04260750882943
- Basic UDI-DI
- 426075088NEOHX
- Direct Marketing DI
- 04260750882943
- EMDN Code
- Y060603 Fingers orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000024244
Other devices from Luna Cybernetics 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