Identity
- Trade Name
- Smart Seal Liner BK 28-6 EUDAMEDSMART SEAL LINER FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- SMART SEAL LINER EUDAMEDSmart Seal Liner BK 28-6 FDA UDI
- Model / Reference
- SBFR28-6 EUDAMEDFDA UDI
- Description
- Smart Seal Liner BK 28-6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980010524 EUDAMEDFDA UDI
- Basic UDI-DI
- 07139801000100979 EUDAMED
- FDA Product Code
- ISS FDA UDI
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- External limb prosthesis socket liner 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
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
Smart Seal Liner BK 28-6 by Alps South, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 07139801000100979 | 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 6db5b302-e6c2-423a-822b-fd844f78fb13 61 fields · synced Jun 18, 2026
- FDA UDI f44f1a17-6b26-416b-9800-bb3690ba590b 33 fields · synced May 29, 2026