Medex
by Medex International Inc. 123 variants
Ref 3S18
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 | Number081005331medexprosthetiCS 00810053310861 | Date10 Feb 2022 | 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- Withdrawn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
- Device Name
- Prosthetic components for lower limb
- Model / Reference
- 3S18
- Primary DI / UDI-DI
- 00810053310861
- Basic UDI-DI
- 081005331medexprosthetiCS
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000011260
- Authorised representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Other devices from Medex International Inc.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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