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Extreme Cushion Liner w/High Density Gel
EUDAMEDClass I (EU MDR)
Ref AKFRHD35-3
Identity
- Trade Name
- Extreme Cushion Liner w/High Density Gel EUDAMED
- Device Name
- EXTREME LINER EUDAMED
- Model / Reference
- AKFRHD35-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00713980035138 EUDAMED
- Basic UDI-DI
- 0713980100010016R EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Extreme Cushion Liner w/High Density Gel by Alps South, LLC — 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 | 0713980100010016R | Class I | Active |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED e862abfd-a6cb-4a1c-84f8-1fed950435b2 61 fields · synced Jun 17, 2026