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Liner
EUDAMEDClass I (EU MDR)
Ref EL-PSLBCFL-M3U001AModel PTLACSL,PTLALSL,PTLBCSL,PTLBLSL,PTLACFJ,PTLALFJ,PTLBCFJ,PTLBLFJ,PSLACFL,PSLALFL,PSLBCFL,PSLBLFL,PSLACSJ,PSLALSJ,PSLBCSJ,PSLBLSJ,PTLNCFD,PTLNLFD
Identity
- Device Name
- Liner EUDAMED
- Model / Reference
- PTLACSL,PTLALSL,PTLBCSL,PTLBLSL,PTLACFJ,PTLALFJ,PTLBCFJ,PTLBLFJ,PSLACFL,PSLALFL,PSLBCFL,PSLBLFL,PSLACSJ,PSLALSJ,PSLBCSJ,PSLBLSJ,PTLNCFD,PTLNLFD EUDAMEDEL-PSLBCFL-M3U001A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894928159 EUDAMED
- Basic UDI-DI
- 471989492LINERRK EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Liner by e-life International Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471989492LINERRK | Class I | Active |
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Manufacturer
- Manufacturer
- e-life International Co., Ltd.
- EUDAMED SRN
- TW-MF-000043583
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 001b5865-cd70-44fe-a870-62f90bbba9cb 61 fields · synced Jul 22, 2026