MAHI by Exoneo
by Exoneo 9 variants
Ref 03CDC2-P3, 03CGC1-P4, 03CGC2-P3, 03CGC1-P3, 03CDC2-P5, 03CDC1-P5, 03CGC2-P2, 03CGC1-P5, 03CGC2-P4, 03CDC2-P6, 03CGC2-P5, 03CDC1-P3
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 | Number37700158050398 | Date3 May 2023 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- 03CDC2-P3, 03CGC1-P4, 03CGC2-P3, 03CGC1-P3, 03CDC2-P5, 03CDC1-P5, 03CGC2-P2, 03CGC1-P5, 03CGC2-P4, 03CDC2-P6, 03CGC2-P5, 03CDC1-P3
- Primary DI / UDI-DI
- 37700158055528, 37700158055382, 37700158054538, 37700158054774, 37700158054606, 37700158055214, 37700158054392, 37700158054088, 37700158054156, 37700158055696, 37700158055450, 37700158053852
- Basic UDI-DI
- 37700158050398
- EMDN Code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000003061
Other devices from Exoneo
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