Sleeve
by e-life International Co., Ltd. Taiwan EUDAMED
Ref EL-PTSR2FD-C00000AModel PTSF3FD,PTSR2FD,PTSR3FD,PTSR6FD
EMDN Y062499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471989492SLEEVEXB | Date25 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sleeve
- Model / Reference
- PTSF3FD, PTSR2FD, PTSR3FD, PTSR6FD, EL-PTSR2FD-C00000A
- Primary DI / UDI-DI
- 04719961409741
- Basic UDI-DI
- 471989492SLEEVEXB
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- TW-MF-000043583
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from e-life International Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 3a7f03d5-e2ba-4fd5-b424-53a1de5387cd