Overlay TF
by Ethnocare Inc. EUDAMED
Active
Ref OVTF-40-SH-VACModel Overlay TF
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number628693190OVERLAYTF8S | Date6 May 2025 | 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- Withdrawn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
- Overlay TF, OVTF-40-SH-VAC
- Primary DI / UDI-DI
- 00628693190411
- Basic UDI-DI
- 628693190OVERLAYTF8S
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CA-MF-000037257
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Ethnocare Inc.
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