Identity
- Trade Name
- (52-57 cm) Reinforced Sleeve Beige EUDAMEDSILICONE SLEEVE FDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- SILICONE SLEEVE EUDAMED(52-57 cm) Reinforced Sleeve Beige FDA UDI
- Model / Reference
- SLR-4XL EUDAMEDFDA UDI
- Description
- (52-57 cm) Reinforced Sleeve Beige FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980001720 EUDAMEDFDA UDI
- Basic UDI-DI
- 0713980100020087E EUDAMED
- FDA Product Code
- ISS 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
- 890.3420 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Mechanical-resistance external ankle-foot prosthesis
(52-57 cm) Reinforced Sleeve Beige 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0713980100020087E | 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 b74f93f3-31b2-49d5-9676-5a3e0b5c4223 61 fields · synced Jul 15, 2026
- FDA UDI 6e104b64-36ba-4f3b-8208-9bd7655a799e 33 fields · synced May 30, 2026