Identity
- Trade Name
- Superior Performance Sleeve EUDAMEDFDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- SUPERIOR PERFORMANCE SLEEVE EUDAMEDFDA UDI
- Model / Reference
- SFP26-3 EUDAMEDFDA UDI
- Description
- Superior Performance Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980008873 EUDAMEDFDA UDI
- Basic UDI-DI
- 07139801000200374 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
Superior Performance Sleeve 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 | 07139801000200374 | 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 9d2e0731-8f98-4bea-8de7-734b202b0f54 61 fields · synced Jun 17, 2026
- FDA UDI 45a15e05-db89-4960-bf4e-c0461eb4abf8 33 fields · synced May 30, 2026