Identity
- Trade Name
- FABRIC COVER EUDAMEDFDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- FABRIC COVER EUDAMEDFDA UDI
- Model / Reference
- CSLE-24 M EUDAMEDFDA UDI
- Description
- Fabric Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980001928 EUDAMEDFDA UDI
- Basic UDI-DI
- 0713980100020106Z EUDAMED
- FDA Product Code
- IPM FDA UDI
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
- GMDN Term
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechanical-resistance external ankle-foot prosthesis
Fabric Cover by Alps South, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0713980100020106Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 57857fcd-8d12-4661-a390-f2c3ee7fb6b5 61 fields · synced Jul 17, 2026
- FDA UDI ad84167f-e2f4-41ce-86ff-571d4e7d6612 33 fields · synced May 30, 2026