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Ultra Seal Gel High Ring Cushion Size 38-3
EUDAMEDFDA UDIClass I (EU MDR)
Ref USHGC38-3
Identity
- Trade Name
- Ultra Seal Gel High Ring Cushion Size 38-3 EUDAMEDULTRA SEAL LINER FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- ULTRA SEAL GEL LINER EUDAMEDUltra Seal Gel High Ring Cushion Liner Size 38-3 FDA UDI
- Model / Reference
- USHGC38-3 EUDAMEDFDA UDI
- Description
- Ultra Seal Gel High Ring Cushion Liner Size 38-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980037637 EUDAMEDFDA UDI
- Basic UDI-DI
- 07139801000102679 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
Ultra Seal Gel High Ring Cushion Size 38-3 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 | 07139801000102679 | 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 0bc2ef7b-a89e-43c3-bcbf-4d6a64d8a137 61 fields · synced Jul 23, 2026
- FDA UDI e7ae08b0-8d12-4d91-9d50-af1d93acda69 33 fields · synced May 30, 2026