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SACH Foot
EUDAMEDClass I (EU MDR)
Ref EL-PFT9127-LY3000BModel PFT90, PFT91, PFT92
Identity
- Device Name
- SACH Foot EUDAMED
- Model / Reference
- PFT90, PFT91, PFT92 EUDAMEDEL-PFT9127-LY3000B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961409376 EUDAMED
- Basic UDI-DI
- 471989492SACHFOOTJG EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
SACH Foot 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 | 471989492SACHFOOTJG | 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 d3e9dac5-4e1f-4fc1-a944-53cca6d7c412 61 fields · synced Jun 18, 2026